Trial Outcomes & Findings for Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment (NCT NCT02174276)
NCT ID: NCT02174276
Last Updated: 2019-06-04
Results Overview
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (\> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2019-06-04
Participant Flow
Participants were enrolled at study sites in North America, Europe, New Zealand, and South Korea. The first participant was screened on 24 July 2014. The last study visit occurred on 30 May 2018.
254 participants were screened.
Participant milestones
| Measure |
TDF 48 Weeks
Participants received tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in optional treatment extension phase \[OTEP\]).
|
TDF + GS-4774 2 YU
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Study Treatment Phase (Weeks 1 to 48)
STARTED
|
27
|
57
|
56
|
55
|
|
Study Treatment Phase (Weeks 1 to 48)
COMPLETED
|
26
|
56
|
53
|
55
|
|
Study Treatment Phase (Weeks 1 to 48)
NOT COMPLETED
|
1
|
1
|
3
|
0
|
|
OTEP (Weeks 48 to 144)
STARTED
|
26
|
54
|
51
|
52
|
|
OTEP (Weeks 48 to 144)
COMPLETED
|
25
|
54
|
48
|
50
|
|
OTEP (Weeks 48 to 144)
NOT COMPLETED
|
1
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
TDF 48 Weeks
Participants received tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in optional treatment extension phase \[OTEP\]).
|
TDF + GS-4774 2 YU
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Study Treatment Phase (Weeks 1 to 48)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Study Treatment Phase (Weeks 1 to 48)
Pregnancy
|
0
|
0
|
1
|
0
|
|
Study Treatment Phase (Weeks 1 to 48)
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
OTEP (Weeks 48 to 144)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
OTEP (Weeks 48 to 144)
Pregnancy
|
0
|
0
|
1
|
0
|
|
OTEP (Weeks 48 to 144)
Withdrew Consent
|
1
|
0
|
1
|
2
|
Baseline Characteristics
Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
Baseline characteristics by cohort
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
46 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
44 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
43 years
STANDARD_DEVIATION 11.6 • n=157 Participants
|
44 years
STANDARD_DEVIATION 10.6 • n=390 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
77 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
33 Participants
n=157 Participants
|
118 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
24 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
45 Participants
n=157 Participants
|
155 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
28 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
9 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
55 Participants
n=157 Participants
|
192 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
17 Participants
n=157 Participants
|
46 Participants
n=390 Participants
|
|
Region of Enrollment
South Korea
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
56 Participants
n=390 Participants
|
|
Region of Enrollment
Romania
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
72 Participants
n=390 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
13 Participants
n=390 Participants
|
|
Baseline Hepatitis B Surface Antigen (HBsAg)
|
3.8 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=99 Participants
|
3.7 log10 IU/mL
STANDARD_DEVIATION 0.82 • n=107 Participants
|
3.7 log10 IU/mL
STANDARD_DEVIATION 0.94 • n=206 Participants
|
3.7 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=157 Participants
|
3.7 log10 IU/mL
STANDARD_DEVIATION 0.84 • n=390 Participants
|
|
Baseline Hepatitis B Virus (HBV) DNA
|
6.0 log10 IU/mL
STANDARD_DEVIATION 1.64 • n=99 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 1.99 • n=107 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 1.97 • n=206 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 1.80 • n=157 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 1.88 • n=390 Participants
|
|
Hepatitis B Envelope Antigen (HBeAg) Status at Baseline
Positive
|
10 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
76 Participants
n=390 Participants
|
|
Hepatitis B Envelope Antigen (HBeAg) Status at Baseline
Negative
|
17 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
34 Participants
n=157 Participants
|
119 Participants
n=390 Participants
|
|
Baseline Alanine Aminotransferase (ALT) Category
≤ ULN
|
6 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
54 Participants
n=390 Participants
|
|
Baseline Alanine Aminotransferase (ALT) Category
> ULN
|
21 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
43 Participants
n=157 Participants
|
141 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set (all participants who were randomized and received at least 1 dose of study drug) with available data were analyzed.
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (\> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).
Outcome measures
| Measure |
TDF 48 Weeks
n=26 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=54 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Mean Change in Serum HBsAg From Baseline to Week 24
|
-0.079 log10 IU/mL
Interval -0.192 to 0.035
|
-0.096 log10 IU/mL
Interval -0.174 to -0.018
|
-0.016 log10 IU/mL
Interval -0.095 to 0.064
|
-0.135 log10 IU/mL
Interval -0.215 to -0.055
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (\> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=54 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=54 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Mean Change in HBsAg From Baseline to Week 12
|
-0.060 log10 IU/mL
Interval -0.165 to 0.044
|
-0.061 log10 IU/mL
Interval -0.133 to 0.011
|
-0.012 log10 IU/mL
Interval -0.086 to 0.061
|
-0.095 log10 IU/mL
Interval -0.168 to -0.021
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (\> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=53 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Mean Change in HBsAg From Baseline to Week 48
|
-0.145 log10 IU/mL
Interval -0.272 to -0.017
|
-0.136 log10 IU/mL
Interval -0.225 to -0.048
|
-0.086 log10 IU/mL
Interval -0.176 to 0.004
|
-0.165 log10 IU/mL
Interval -0.254 to -0.075
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg Loss at Week 24
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg Loss at Week 48
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
≥ 0.5 and < 1.0 log10 IU/mL Decline
|
3.7 percentage of participants
|
3.5 percentage of participants
|
1.8 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
≥ 1.0 and < 2.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
3.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
≥ 2.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
≥ 2.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
≥ 0.5 and < 1.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
1.8 percentage of participants
|
1.8 percentage of participants
|
7.3 percentage of participants
|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
≥ 1.0 and < 2.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
5.3 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
≥ 1.0 and < 2.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
5.3 percentage of participants
|
1.8 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
≥ 2.0 log10 IU/mL Decline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
≥ 0.5 and < 1.0 log10 IU/mL Decline
|
11.1 percentage of participants
|
1.8 percentage of participants
|
7.1 percentage of participants
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=10 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=22 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=23 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=21 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With HBeAg Loss at Week 24
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=10 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=22 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=23 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=21 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With HBeAg Loss at Week 48
|
0.0 percentage of participants
|
4.5 percentage of participants
|
8.7 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=10 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=22 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=23 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=21 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Outcome measures
| Measure |
TDF 48 Weeks
n=10 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=22 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=23 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=21 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.3 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set with available data were analyzed. The missing equals excluded approach was used.
The LLOQ was defined as 20 IU/mL.
Outcome measures
| Measure |
TDF 48 Weeks
n=26 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=53 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
|
50.0 percentage of participants
|
58.9 percentage of participants
|
58.5 percentage of participants
|
63.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with available data were analyzed. The missing equals excluded approach was used.
The LLOQ was defined as 20 IU/mL.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=54 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants With HBV DNA < LLOQ at Week 48
|
70.4 percentage of participants
|
69.6 percentage of participants
|
69.2 percentage of participants
|
76.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set were analyzed.
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been \< 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Virologic Breakthrough at Week 24
|
0.0 percentage of participants
|
1.8 percentage of participants
|
1.8 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set were analyzed.
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been \< 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Outcome measures
| Measure |
TDF 48 Weeks
n=27 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Virologic Breakthrough at Week 48
|
3.7 percentage of participants
|
5.3 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants with at least 24 weeks of exposure to TDF and with HBV DNA ≥ 69 IU/mL at Week 48 or Early Discontinuation were analyzed.
Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing.
Outcome measures
| Measure |
TDF 48 Weeks
n=5 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=12 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=13 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=8 Participants
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
TDF 48 Weeks
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
TDF + GS-4774 2 YU
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
TDF + GS-4774 10 YU
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
TDF + GS-4774 40 YU
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDF 48 Weeks
n=27 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Infections and infestations
Meningitis tuberculous
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
TDF 48 Weeks
n=27 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 2 YU
n=57 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 10 YU
n=56 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
TDF + GS-4774 40 YU
n=55 participants at risk
Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.3%
3/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.0%
4/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
3/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.5%
6/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.9%
10/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
11/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.7%
6/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.4%
9/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
18.5%
5/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.5%
10/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
21/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
22/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.3%
3/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
3/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
24.6%
14/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
20/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
61.8%
34/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site induration
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.0%
4/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.9%
5/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
32.7%
18/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site oedema
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.1%
16/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
32/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
81.8%
45/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.0%
4/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
32.1%
18/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
32.7%
18/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
4/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
15.8%
9/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
19.6%
11/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
22/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
3/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.3%
3/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.7%
7/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
3/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
5/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.4%
9/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.9%
6/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
3/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.5%
6/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.5%
6/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.2%
13/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
22/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
15.8%
9/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
30.4%
17/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
36.4%
20/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.3%
7/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
8/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.5%
8/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
3/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.4%
2/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.5%
2/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.8%
5/57 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.8%
1/56 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Adverse Events: First dose date up to last dose date (maximum exposure: 3 years); All-Cause Mortality: First dose date up to 3 years
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER