Trial Outcomes & Findings for ODYSSEY (PENTA 20) (NCT NCT02259127)

Last Updated: 2025-07-29

Results Overview

Treatment failure by 96 weeks. Estimated using time to the first occurrence of any of the following components: * Insufficient virological response defined as \< 1 log10 drop at week 24 and switch to second/third line ART for treatment failure * Viral Load (VL)\>400 c/ml at or after 36 weeks confirmed by next visit * Death due to any cause * Any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, adjudicated by the Endpoint Review Committee

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

792 participants

Primary outcome timeframe

96 weeks post randomisation

Results posted on

2025-07-29

Participant Flow

Recruitment to the \>=14kg cohort took place between 20th September 2016 and 22nd June 2018 in 8 countries (Germany, Portugal, South Africa, Spain, Thailand, Uganda, United Kingdom, and Zimbabwe) across 29 centres. Recruitment to the \<14kg cohort took place between 5th July 2018 and 26th August 2019 in the African countries across 7 centres. The results published relate to the randomised phase of the study for the \>=14kg cohort and \<14kg cohort.

\>=14kg: 819 children assessed for eligibility. 109 were ineligible: 102 failed eligibility criteria, 3 didn't return in window and 4 other reasons. Also, 3 children randomised in error: 1 not ART naïve in ODYSSEY A and 3 randomised before DTG available for weight. \<14kg: 102 children assessed for eligibility. 17 were ineligible: 14 failed eligibility criteria, 1 died before enrolment, 1 carer declined bloods and 1 ineligible due to no protocol approval at site to recruit \<14kg cohort.

Participant milestones

Participant milestones
Measure	Dolutegravir (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Overall Study STARTED	350	357	42	43
Overall Study ODYSSEY A	154	157	35	37
Overall Study ODYSSEY B	196	200	7	6
Overall Study COMPLETED	350	357	42	43
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Row population differs differs from overall given that weight-for-age Z scores only estimated for participants aged 10 and below.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Total n=792 Participants Total of all reporting groups
Age, Continuous	12.2 years n=350 Participants	12.1 years n=357 Participants	1.3 years n=42 Participants	1.5 years n=43 Participants	11.4 years n=792 Participants
Age, Customized <6 months	0 Participants n=350 Participants	0 Participants n=357 Participants	11 Participants n=42 Participants	8 Participants n=43 Participants	19 Participants n=792 Participants
Age, Customized 6 months-<1 year	0 Participants n=350 Participants	0 Participants n=357 Participants	5 Participants n=42 Participants	8 Participants n=43 Participants	13 Participants n=792 Participants
Age, Customized 1-<2 years	0 Participants n=350 Participants	0 Participants n=357 Participants	22 Participants n=42 Participants	22 Participants n=43 Participants	44 Participants n=792 Participants
Age, Customized 2-<6 years	15 Participants n=350 Participants	11 Participants n=357 Participants	4 Participants n=42 Participants	5 Participants n=43 Participants	35 Participants n=792 Participants
Age, Customized 6-<12 years	153 Participants n=350 Participants	164 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	317 Participants n=792 Participants
Age, Customized 12-<18 years	182 Participants n=350 Participants	182 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	364 Participants n=792 Participants
Sex: Female, Male Female	174 Participants n=350 Participants	171 Participants n=357 Participants	26 Participants n=42 Participants	18 Participants n=43 Participants	389 Participants n=792 Participants
Sex: Female, Male Male	176 Participants n=350 Participants	186 Participants n=357 Participants	16 Participants n=42 Participants	25 Participants n=43 Participants	403 Participants n=792 Participants
Race/Ethnicity, Customized Black African	310 Participants n=350 Participants	313 Participants n=357 Participants	41 Participants n=42 Participants	42 Participants n=43 Participants	706 Participants n=792 Participants
Race/Ethnicity, Customized Asian	28 Participants n=350 Participants	32 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	60 Participants n=792 Participants
Race/Ethnicity, Customized White	5 Participants n=350 Participants	1 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	6 Participants n=792 Participants
Race/Ethnicity, Customized Other	7 Participants n=350 Participants	11 Participants n=357 Participants	1 Participants n=42 Participants	1 Participants n=43 Participants	20 Participants n=792 Participants
Region of Enrollment South Africa	61 Participants n=350 Participants	83 Participants n=357 Participants	8 Participants n=42 Participants	12 Participants n=43 Participants	164 Participants n=792 Participants
Region of Enrollment Uganda	170 Participants n=350 Participants	161 Participants n=357 Participants	22 Participants n=42 Participants	21 Participants n=43 Participants	374 Participants n=792 Participants
Region of Enrollment Europe	12 Participants n=350 Participants	13 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	25 Participants n=792 Participants
Region of Enrollment Zimbabwe	79 Participants n=350 Participants	67 Participants n=357 Participants	12 Participants n=42 Participants	10 Participants n=43 Participants	168 Participants n=792 Participants
Region of Enrollment Thailand	28 Participants n=350 Participants	33 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	61 Participants n=792 Participants
ODYSSEY A/B ODYSSEY A (starting first-line ART)	154 Participants n=350 Participants	157 Participants n=357 Participants	35 Participants n=42 Participants	37 Participants n=43 Participants	383 Participants n=792 Participants
ODYSSEY A/B ODYSSEY B (Switching to second-line ART)	196 Participants n=350 Participants	200 Participants n=357 Participants	7 Participants n=42 Participants	6 Participants n=43 Participants	409 Participants n=792 Participants
Weight <6kg	0 Participants n=350 Participants	0 Participants n=357 Participants	11 Participants n=42 Participants	12 Participants n=43 Participants	23 Participants n=792 Participants
Weight 6-<10kg	0 Participants n=350 Participants	0 Participants n=357 Participants	20 Participants n=42 Participants	20 Participants n=43 Participants	40 Participants n=792 Participants
Weight 10-<14kg	0 Participants n=350 Participants	0 Participants n=357 Participants	11 Participants n=42 Participants	11 Participants n=43 Participants	22 Participants n=792 Participants
Weight 14-<20kg	39 Participants n=350 Participants	43 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	82 Participants n=792 Participants
Weight 20-<25kg	71 Participants n=350 Participants	64 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	135 Participants n=792 Participants
Weight 25-<30kg	58 Participants n=350 Participants	59 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	117 Participants n=792 Participants
Weight 30-<35kg	38 Participants n=350 Participants	51 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	89 Participants n=792 Participants
Weight 35-<40kg	29 Participants n=350 Participants	32 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	61 Participants n=792 Participants
Weight >=40kg	115 Participants n=350 Participants	108 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	223 Participants n=792 Participants
Weight-for-age z-score <-3	4 Participants n=350 Participants	4 Participants n=357 Participants	14 Participants n=42 Participants	13 Participants n=43 Participants	35 Participants n=792 Participants
Weight-for-age z-score -3-<-2	20 Participants n=350 Participants	12 Participants n=357 Participants	7 Participants n=42 Participants	6 Participants n=43 Participants	45 Participants n=792 Participants
Weight-for-age z-score -2-<0	78 Participants n=350 Participants	83 Participants n=357 Participants	18 Participants n=42 Participants	21 Participants n=43 Participants	200 Participants n=792 Participants
Weight-for-age z-score >=0	14 Participants n=350 Participants	19 Participants n=357 Participants	3 Participants n=42 Participants	3 Participants n=43 Participants	39 Participants n=792 Participants
Weight-for-age z-score missing	234 Participants n=350 Participants	239 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	473 Participants n=792 Participants
BMI-for-age z-score <-3	22 Participants n=350 Participants	11 Participants n=357 Participants	3 Participants n=42 Participants	6 Participants n=43 Participants	42 Participants n=792 Participants
BMI-for-age z-score -3-<-2	20 Participants n=350 Participants	28 Participants n=357 Participants	6 Participants n=42 Participants	6 Participants n=43 Participants	60 Participants n=792 Participants
BMI-for-age z-score -2-<0	216 Participants n=350 Participants	219 Participants n=357 Participants	20 Participants n=42 Participants	14 Participants n=43 Participants	469 Participants n=792 Participants
BMI-for-age z-score >=0	92 Participants n=350 Participants	99 Participants n=357 Participants	13 Participants n=42 Participants	17 Participants n=43 Participants	221 Participants n=792 Participants
BMI-for-age z-score missing	0 Participants n=350 Participants	0 Participants n=357 Participants	0 Participants n=42 Participants	0 Participants n=43 Participants	0 Participants n=792 Participants
CD4% <15%	121 Participants n=350 Participants	108 Participants n=357 Participants	7 Participants n=42 Participants	11 Participants n=43 Participants	247 Participants n=792 Participants
CD4% 15-<30%	152 Participants n=350 Participants	147 Participants n=357 Participants	22 Participants n=42 Participants	18 Participants n=43 Participants	339 Participants n=792 Participants
CD4% >=30%	77 Participants n=350 Participants	102 Participants n=357 Participants	12 Participants n=42 Participants	11 Participants n=43 Participants	202 Participants n=792 Participants
CD4% Missing	0 Participants n=350 Participants	0 Participants n=357 Participants	1 Participants n=42 Participants	3 Participants n=43 Participants	4 Participants n=792 Participants
Viral Load copies/mL <10,000	93 Participants n=350 Participants	123 Participants n=357 Participants	4 Participants n=42 Participants	7 Participants n=43 Participants	227 Participants n=792 Participants
Viral Load copies/mL 10,000-<100,000	159 Participants n=350 Participants	158 Participants n=357 Participants	13 Participants n=42 Participants	5 Participants n=43 Participants	335 Participants n=792 Participants
Viral Load copies/mL >=100,000	98 Participants n=350 Participants	75 Participants n=357 Participants	25 Participants n=42 Participants	26 Participants n=43 Participants	224 Participants n=792 Participants
Viral Load copies/mL Missing	0 Participants n=350 Participants	1 Participants n=357 Participants	0 Participants n=42 Participants	5 Participants n=43 Participants	6 Participants n=792 Participants
History of WHO Staging Stage 1-2	253 Participants n=350 Participants	265 Participants n=357 Participants	31 Participants n=42 Participants	25 Participants n=43 Participants	574 Participants n=792 Participants
History of WHO Staging Stage 3	69 Participants n=350 Participants	60 Participants n=357 Participants	6 Participants n=42 Participants	8 Participants n=43 Participants	143 Participants n=792 Participants
History of WHO Staging Stage 4	28 Participants n=350 Participants	32 Participants n=357 Participants	5 Participants n=42 Participants	10 Participants n=43 Participants	75 Participants n=792 Participants
CD4 <200 cells/mm^3	88 Participants n=350 Participants	70 Participants n=357 Participants	3 Participants n=42 Participants	4 Participants n=43 Participants	165 Participants n=792 Participants
CD4 200 to <500 cells/mm^3	118 Participants n=350 Participants	114 Participants n=357 Participants	2 Participants n=42 Participants	3 Participants n=43 Participants	237 Participants n=792 Participants
CD4 >=500 cells/mm^3	144 Participants n=350 Participants	173 Participants n=357 Participants	36 Participants n=42 Participants	33 Participants n=43 Participants	386 Participants n=792 Participants
CD4 Missing	0 Participants n=350 Participants	0 Participants n=357 Participants	1 Participants n=42 Participants	3 Participants n=43 Participants	4 Participants n=792 Participants
Weight	30.4 kilogram(s) n=350 Participants	31.0 kilogram(s) n=357 Participants	8.1 kilogram(s) n=42 Participants	8.2 kilogram(s) n=43 Participants	28.7 kilogram(s) n=792 Participants
Weight-for-age z-score	-1.2 z-score n=116 Participants • Row population differs differs from overall given that weight-for-age Z scores only estimated for participants aged 10 and below.	-0.9 z-score n=118 Participants • Row population differs differs from overall given that weight-for-age Z scores only estimated for participants aged 10 and below.	-2.1 z-score n=42 Participants • Row population differs differs from overall given that weight-for-age Z scores only estimated for participants aged 10 and below.	-1.8 z-score n=43 Participants • Row population differs differs from overall given that weight-for-age Z scores only estimated for participants aged 10 and below.	-1.2 z-score n=319 Participants • Row population differs differs from overall given that weight-for-age Z scores only estimated for participants aged 10 and below.
BMI-for-age z-score	-0.6 z-score n=350 Participants	-0.6 z-score n=357 Participants	-1.1 z-score n=42 Participants	-0.7 z-score n=43 Participants	-0.6 z-score n=792 Participants
CD4%	20 % n=350 Participants • Data on CD4% at baseline were missing for four participants.	22 % n=357 Participants • Data on CD4% at baseline were missing for four participants.	24 % n=41 Participants • Data on CD4% at baseline were missing for four participants.	23 % n=40 Participants • Data on CD4% at baseline were missing for four participants.	21 % n=788 Participants • Data on CD4% at baseline were missing for four participants.
CD4	444 cells/mm^3 n=350 Participants • Data on CD4 at baseline were missing for four participants.	486 cells/mm^3 n=357 Participants • Data on CD4 at baseline were missing for four participants.	1639 cells/mm^3 n=41 Participants • Data on CD4 at baseline were missing for four participants.	1221 cells/mm^3 n=40 Participants • Data on CD4 at baseline were missing for four participants.	494 cells/mm^3 n=788 Participants • Data on CD4 at baseline were missing for four participants.
Log 10 Viral load copies/mL	4.5 copies/mL n=350 Participants • Data on viral load at baseline were missing for six participants.	4.4 copies/mL n=356 Participants • Data on viral load at baseline were missing for six participants.	5.2 copies/mL n=42 Participants • Data on viral load at baseline were missing for six participants.	5.4 copies/mL n=38 Participants • Data on viral load at baseline were missing for six participants.	4.5 copies/mL n=786 Participants • Data on viral load at baseline were missing for six participants.

PRIMARY outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Difference in Proportion With Failure (Clinical or Virological) Insufficient virological response	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Difference in Proportion With Failure (Clinical or Virological) Confirmed VL>=400 copies/mL	40 Participants	64 Participants	9 Participants	16 Participants	10 Participants	26 Participants	30 Participants	38 Participants
Difference in Proportion With Failure (Clinical or Virological) Severe WHO 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Difference in Proportion With Failure (Clinical or Virological) WHO 4	7 Participants	5 Participants	1 Participants	1 Participants	5 Participants	5 Participants	2 Participants	0 Participants
Difference in Proportion With Failure (Clinical or Virological) Death	0 Participants	2 Participants	2 Participants	4 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Proportion of children with viral load suppression \<50 c/ml at 96 weeks.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=335 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=330 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=35 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=36 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=146 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=140 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=189 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=192 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
HIV-1 RNA <50c/ml at 96 Weeks	270 Participants	252 Participants	27 Participants	19 Participants	117 Participants	113 Participants	153 Participants	139 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Proportion of children with viral load suppression \<400 c/ml at 96 weeks

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=337 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=333 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=36 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=36 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=146 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=140 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=191 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=193 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
HIV-1 RNA <400c/mL at 96 Weeks	299 Participants	285 Participants	33 Participants	26 Participants	129 Participants	124 Participants	170 Participants	161 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Reporting mean change from the global baseline value across both arms.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Mean Change in CD4 Count From Baseline to Week 96	265 cells/mm^3 Standard Error 17	230 cells/mm^3 Standard Error 17	72 cells/mm^3 Standard Error 116	51 cells/mm^3 Standard Error 118	311 cells/mm^3 Standard Error 23	267 cells/mm^3 Standard Error 24	228 cells/mm^3 Standard Error 24	202 cells/mm^3 Standard Error 24

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Reporting mean change from global baseline value across both arms.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Mean Change in Total Cholesterol From Baseline to Week 96	-5.0 mg/dl Standard Error 1.5	9.9 mg/dl Standard Error 1.5	4.5 mg/dl Standard Error 5.6	29.6 mg/dl Standard Error 5.9	2.1 mg/dl Standard Error 2.3	19.6 mg/dl Standard Error 2.3	-10.5 mg/dl Standard Error 1.8	2.8 mg/dl Standard Error 1.8

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Incidence of serious adverse events

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Serious Adverse Events	35 participants with events	40 participants with events	11 participants with events	11 participants with events	23 participants with events	27 participants with events	12 participants with events	13 participants with events

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Incidence of new clinical and laboratory grade 3 and 4 adverse events

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Grade 3 or Above Clinical and Laboratory Adverse Events	73 participants with events	86 participants with events	19 participants with events	21 participants with events	48 participants with events	43 participants with events	25 participants with events	43 participants with events

SECONDARY outcome

Timeframe: Randomised Phase

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Incidence of adverse events (of any grade) leading to treatment modification

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Adverse Events Leading to ART Modification Any Grade	5 participants with events	17 participants with events	0 participants with events	2 participants with events	3 participants with events	8 participants with events	2 participants with events	9 participants with events

SECONDARY outcome

Timeframe: 48 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Treatment failure by 48 weeks. Difference in proportion with clinical or virological failure (as defined above)

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Treatment Failure by 48 Weeks Insufficient virologic response	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Treatment Failure by 48 Weeks Confirmed viral load >400c/ml	13 Participants	31 Participants	4 Participants	11 Participants	4 Participants	12 Participants	9 Participants	19 Participants
Treatment Failure by 48 Weeks Severe WHO stage 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Treatment Failure by 48 Weeks WHO stage 4	7 Participants	5 Participants	1 Participants	1 Participants	5 Participants	5 Participants	2 Participants	0 Participants
Treatment Failure by 48 Weeks Death	0 Participants	2 Participants	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 144 weeks post randomisation

Population: Note: analysis could not be performed in \<14kg cohort due to shorter follow-up

Treatment failure by 144 weeks. Difference in proportion with clinical or virological failure (as defined above)

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=157 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Treatment Failure by 144 Weeks Insufficient virologic response	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants	1 Participants	—	—
Treatment Failure by 144 Weeks Confirmed viral load>400c/mL	48 Participants	76 Participants	13 Participants	28 Participants	35 Participants	48 Participants	—	—
Treatment Failure by 144 Weeks Severe WHO stage 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Treatment Failure by 144 Weeks WHO stage 4	8 Participants	5 Participants	6 Participants	5 Participants	2 Participants	0 Participants	—	—
Treatment Failure by 144 Weeks Death	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Rate of clinical events : WHO 4, severe WHO 3 events and death

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
WHO 4, Severe WHO 3 Events and Death	8 Participants	8 Participants	3 Participants	6 Participants	6 Participants	6 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Per protocol: treatment failure by 96 weeks post randomisation

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=340 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=337 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=150 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=145 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=190 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=192 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Per Protocol: Treatment Failure by 96 Weeks	44 Participants	62 Participants	12 Participants	20 Participants	13 Participants	28 Participants	31 Participants	34 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Shown are the numbers of participants with resistance after virologic failure, among those with virologic failure by week 96 who had a post-treatment failure resistance test available for the drug class.

Any drug class resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=11 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=29 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=29 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=40 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=6 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=12 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=2 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=3 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Any Drug Class Resistance After Virologic Failure	0 Participants	28 Participants	23 Participants	36 Participants	6 Participants	12 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

NRTI resistance after virologic failure 96 weeks post randomisation. Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=11 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=29 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=29 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=40 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=6 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=12 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=2 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=3 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
NRTI Resistance After Virologic Failure	0 Participants	18 Participants	21 Participants	31 Participants	1 Participants	10 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

NNRTI resistance after virologic failure 96 weeks post randomisation. Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=11 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=29 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=29 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=40 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=6 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=12 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=2 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=3 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
NNRTI Resistance After Virologic Failure	0 Participants	27 Participants	22 Participants	36 Participants	6 Participants	11 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

PI resistance after virologic failure 96 weeks post randomisation. Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=11 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=29 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=29 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=40 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=6 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=12 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=2 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=3 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
PI Resistance After Virologic Failure	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 96 weeks post randomisation

INSTI resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=11 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=22 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=5 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=2 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
INSTI Resistance After Virologic Failure	0 Participants	4 Participants	0 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Dolutegravir - ODYSSEY A (\>=14kg cohort): 0 participants had resistance to INSTI post failure Standard of Care - ODYSSEY B (\<14kg Cohort) - 0 participants with virological failure and any gene sequenced at baseline and post-failure.

Emerging resistance to any drug class after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom resistance test was available post-failure and at baseline, and exposed to drug-class during trial.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=21 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=6 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=6 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=5 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=5 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=2 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Emerging Resistance to Any Drug Class After Virologic Failure	—	97 percentage of participants	22 percentage of participants	19 percentage of participants	0 percentage of participants	100 percentage of participants	50 percentage of participants	—

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Dolutegravir - ODYSSEY A (\>=14kg cohort) - 0 participants had resistance post failure. Dolutegravir - ODYSSEY A (\<14kg Cohort) and Standard of Care - ODYSSEY B (\<14kg Cohort) - 0 participants with virological failure, exposed to drug-class, and gene sequenced at baseline and post-failure.

NRTI emerging resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom a resistance test was available post-failure and at baseline, and exposed to drug-class during trial.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=13 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=2 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=3 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=5 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=1 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
NRTI Emerging Resistance After Virologic Failure	—	62 percentage of participants	8 percentage of participants	10 percentage of participants	—	100 percentage of participants	100 percentage of participants	—

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Emergent drug resistance estimated only in participants exposed to drug class during trial (DTG arm not exposed to NNRTI class). Standard of Care - ODYSSEY A (\<14kg Cohort) and Standard of Care - ODYSSEY B (\<14kg Cohort) - 0 participants with virological failure, exposed to drug-class, and gene sequenced at baseline and post-failure.

NNRTI emerging resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom a resistance test was available post-failure and at baseline, and exposed to drug-class during trial.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=19 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=2 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
NNRTI Emerging Resistance After Virologic Failure	88 percentage of participants	100 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Emergent drug resistance estimated only in participants exposed to drug class during trial (DTG arm not exposed to PI class). Standard of Care - ODYSSEY A (\>=14kg cohort) - 0 participants had resistance post failure. Standard of Care - ODYSSEY B (\<14kg Cohort) - 0 participants with virological failure, exposed to drug-class, and gene sequenced at baseline and post-failure.

PI emerging resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom a resistance test was available post-failure and at baseline, and exposed to drug-class during trial.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=2 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=1 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
PI Emerging Resistance After Virologic Failure	—	5 percentage of participants	100 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 96 weeks post randomisation

Population: Emergent drug resistance estimated only in participants exposed to drug class during trial (SOC arm not exposed to INSTI drug class). Dolutegravir - ODYSSEY A (\>=14kg cohort) - 0 participants had resistance post failure.

INSTI emerging resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom a resistance test was available post-failure and at baseline, and exposed to drug-class during trial. The integrase gene was not sequenced for the standard of care arm.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=4 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=5 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=2 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
INSTI Emerging Resistance After Virologic Failure	—	18 percentage of participants	0 percentage of participants	50 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Time to any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events adjudicated by the Endpoint Review Committee. Reported in \>=14kg and \<14kg papers. \>=14kg cohort paper (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

The proportion of adherence questionnaires where the participant/carer reports missing a dose within the last week will be compared between randomised groups. Reported in \>=14kg and \<14kg papers. \>=14kg cohort paper (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Adapted from the Euro Quality of Life Questionnaire (Qol)-5D questionnaire The EQ5D-3L (3-level version of EQ-5D) questionnaire contains five questions about the participants' quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has three dimensions: no problems, some problems, and extreme problems. This analysis reports whether the participant reports any problems (some or extreme). Percentages are of participants completing at least one EQ5D-3L questionnaire during follow-up. Reported in \>=14kg cohort paper (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Number of participants reported to have problems with size, taste or swallowing of the medicines as assessed by Acceptability questionnaire Reported in \>=14kg and \<14kg papers. \>=14kg cohort paper (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Mean change in weight from baseline to week 96

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Mean Change in Weight From Baseline	7.1 kg Standard Error 0.3	6.1 kg Standard Error 0.3	5.0 kg Standard Error 0.2	5.1 kg Standard Error 0.2	7.8 kg Standard Error 0.4	6.5 kg Standard Error 0.4	6.7 kg Standard Error 0.3	5.9 kg Standard Error 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 96 weeks post randomisation

Population: Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13).

Mean change in BMI-for-age from baseline to week 96. Reporting mean change from the global baseline value across both arms. z-scores (standard scores) are the number of standard deviations the observed data is above or below the population (z-score of 0 represents the population median). Positive z-scores represent the standard deviations above the median and negative z-scores represent the standard deviations below the median. BMI-for-age Z scores indicate: \<-3SD severe thinness; \<-2SD thinness; -2 to 1SD healthy weight; \>1SD overweight; \>2SD obese.

Outcome measures

Outcome measures
Measure	Dolutegravir (>=14kg Cohort) n=350 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 Participants Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 Participants Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 Participants Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 Participants Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Mean Change in BMI-for-age Z-score From Baseline	0.24 Z-score Standard Error 0.04	0.11 Z-score Standard Error 0.04	1.1 Z-score Standard Error 0.3	1.5 Z-score Standard Error 0.3	0.36 Z-score Standard Error 0.07	0.20 Z-score Standard Error 0.07	0.14 Z-score Standard Error 0.05	0.04 Z-score Standard Error 0.05

Adverse Events

Dolutegravir (>=14kg Cohort)

Serious events: 35 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard of Care (>=14kg Cohort)

Serious events: 40 serious events

Other events: 0 other events

Deaths: 3 deaths

Dolutegravir (<14kg Cohort)

Serious events: 11 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard of Care (<14kg Cohort)

Serious events: 11 serious events

Other events: 0 other events

Deaths: 4 deaths

Dolutegravir - ODYSSEY A (>=14kg Cohort)

Serious events: 23 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard of Care - ODYSSEY A (>=14kg Cohort)

Serious events: 27 serious events

Other events: 0 other events

Deaths: 2 deaths

Dolutegravir - ODYSSEY B (>=14kg Cohort)

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care - ODYSSEY B (>=14kg Cohort)

Serious events: 13 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dolutegravir (>=14kg Cohort) n=350 participants at risk Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (>=14kg Cohort) n=357 participants at risk Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir (<14kg Cohort) n=42 participants at risk Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG).	Standard of Care (<14kg Cohort) n=43 participants at risk Active comparator arm. SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors	Dolutegravir - ODYSSEY A (>=14kg Cohort) n=154 participants at risk Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY A: Children starting first-line ART	Standard of Care - ODYSSEY A (>=14kg Cohort) n=157 participants at risk Active comparator arm. ODYSSEY A: children starting first-line ART SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor	Dolutegravir - ODYSSEY B (>=14kg Cohort) n=196 participants at risk Experimental arm. DTG + 2 nucleoside transcriptase inhibitors. IMP product Dolutegravir (DTG). ODYSSEY B: children starting second-line ART.	Standard of Care - ODYSSEY B (>=14kg Cohort) n=200 participants at risk Active comparator arm. ODYSSEY B: children starting second-line ART. SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Vascular disorders Vascular disorders	0.29% 1/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.29% 1/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.56% 2/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.51% 1/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.50% 1/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Immune system disorders Immune system disorders	0.29% 1/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions	0.00% 0/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.28% 1/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
General disorders General disorders and administration site conditions	0.00% 0/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.28% 1/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.50% 1/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Psychiatric disorders Psychiatric disorders	0.57% 2/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.56% 2/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.3% 2/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.3% 2/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.00% 0/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.56% 2/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	2.4% 1/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.3% 2/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Investigations Investigations	0.57% 2/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	2.3% 1/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.3% 2/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Cardiac disorders Cardiac disorders	0.29% 1/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.86% 3/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.84% 3/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	2.4% 1/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	2.3% 1/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.0% 2/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.0% 2/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.00% 0/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.28% 1/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Nervous system disorders Nervous system disorders	0.86% 3/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.1% 4/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.3% 2/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	2.5% 4/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.51% 1/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Gastrointestinal disorders Gastrointestinal disorders	0.00% 0/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.28% 1/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Hepatobiliary disorders Hepatobiliary disorders	0.29% 1/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Renal and urinary disorders Renal and urinary disorders	0.57% 2/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	1.3% 2/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.57% 2/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.28% 1/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.51% 1/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.57% 2/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.28% 1/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.64% 1/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.51% 1/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.29% 1/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	4.8% 2/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	2.3% 1/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.65% 1/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	0.00% 0/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)
Infections and infestations Infections and infestations	7.1% 25/350 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	6.4% 23/357 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	21.4% 9/42 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	20.9% 9/43 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	12.3% 19/154 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	8.9% 14/157 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	3.1% 6/196 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)	4.5% 9/200 • Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). Non-serious Adverse Events (AEs):There was no single diagnosis reported for 5% or more of participants. Details of all AEs are reported in the supplementary materials of the \>=14kg cohort paper (including by ODYSSEY A/B) (https://www.nejm.org/doi/full/10.1056/NEJMoa2108793) and the \<14kg cohort paper (https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00163-1/fulltext)

Other adverse events

Adverse event data not reported

Additional Information

Prof Diana M Gibb (Chief Investigator)

MRC CTU at UCL

Phone: +44 (0) 207 670 4700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place