Trial Outcomes & Findings for Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine (NCT NCT00737568)
NCT ID: NCT00737568
Last Updated: 2016-03-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
280 participants
Primary outcome timeframe
Week 96
Results posted on
2016-03-11
Participant Flow
Participants were enrolled at study sites in North America, Europe, and New Zealand. The first participant was screened on 30 September 2008. The last study visit occurred on 09 February 2015.
752 participants were screened. Randomization was stratified by hepatitis B e antigen (HBeAg) status (negative or positive) and alanine aminotransferase (ALT) level (≥ 2 × upper limit of normal \[ULN\] or \< 2 × ULN) at screening.
Participant milestones
| Measure |
Tenofovir DF
Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
|
FTC/Tenofovir DF
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Treatment Period Through Week 240
STARTED
|
141
|
139
|
|
Treatment Period Through Week 240
COMPLETED
|
121
|
118
|
|
Treatment Period Through Week 240
NOT COMPLETED
|
20
|
21
|
|
Treatment-Free Follow-up (TFFU) Period
STARTED
|
38
|
37
|
|
Treatment-Free Follow-up (TFFU) Period
COMPLETED
|
12
|
19
|
|
Treatment-Free Follow-up (TFFU) Period
NOT COMPLETED
|
26
|
18
|
Reasons for withdrawal
| Measure |
Tenofovir DF
Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
|
FTC/Tenofovir DF
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Treatment Period Through Week 240
Investigator's Discretion
|
6
|
5
|
|
Treatment Period Through Week 240
Withdrew Consent
|
5
|
6
|
|
Treatment Period Through Week 240
Safety, Tolerability, or Efficacy Reason
|
3
|
4
|
|
Treatment Period Through Week 240
Lost to Follow-up
|
3
|
3
|
|
Treatment Period Through Week 240
Protocol Violation
|
2
|
3
|
|
Treatment Period Through Week 240
Study Discontinued by Sponsor
|
1
|
0
|
|
Treatment-Free Follow-up (TFFU) Period
Started Commercial Therapy
|
25
|
17
|
|
Treatment-Free Follow-up (TFFU) Period
Death
|
0
|
1
|
|
Treatment-Free Follow-up (TFFU) Period
Withdrew Consent
|
1
|
0
|
Baseline Characteristics
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
Baseline characteristics by cohort
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 13.63 • n=99 Participants
|
46.3 years
STANDARD_DEVIATION 13.56 • n=107 Participants
|
46.7 years
STANDARD_DEVIATION 13.58 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
52 participants
n=99 Participants
|
42 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
83 participants
n=99 Participants
|
89 participants
n=107 Participants
|
172 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
47 participants
n=99 Participants
|
43 participants
n=107 Participants
|
90 participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
13 participants
n=99 Participants
|
19 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
17 participants
n=99 Participants
|
14 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
17 participants
n=99 Participants
|
19 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
15 participants
n=99 Participants
|
13 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
ALT Normal at Baseline
Abnormal
|
79 participants
n=99 Participants
|
83 participants
n=107 Participants
|
162 participants
n=206 Participants
|
|
ALT Normal at Baseline
Normal
|
62 participants
n=99 Participants
|
56 participants
n=107 Participants
|
118 participants
n=206 Participants
|
|
Hepatitis B Virus (HBV) DNA Level at Baseline
|
6.40 log_10 copies/mL
STANDARD_DEVIATION 1.826 • n=99 Participants
|
6.53 log_10 copies/mL
STANDARD_DEVIATION 1.968 • n=107 Participants
|
6.46 log_10 copies/mL
STANDARD_DEVIATION 1.896 • n=206 Participants
|
|
HBV e Antigen (HBeAg) Status at Baseline
Negative
|
76 participants
n=99 Participants
|
71 participants
n=107 Participants
|
147 participants
n=206 Participants
|
|
HBV e Antigen (HBeAg) Status at Baseline
Positive
|
65 participants
n=99 Participants
|
68 participants
n=107 Participants
|
133 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 96Population: Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96
|
89.4 percentage of participants
|
86.3 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 144, 192, and 240Population: Full Analysis Set, missing = failure method
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240
Week 48
|
81.6 percentage of participants
|
84.2 percentage of participants
|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240
Week 144
|
87.2 percentage of participants
|
84.9 percentage of participants
|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240
Week 192
|
86.5 percentage of participants
|
85.6 percentage of participants
|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240
Week 240
|
83.0 percentage of participants
|
82.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 96, 144, 192, and 240Population: Full Analysis Set, missing = failure method
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240
Week 48
|
76.6 percentage of participants
|
77.7 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240
Week 96
|
85.8 percentage of participants
|
83.5 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240
Week 144
|
86.5 percentage of participants
|
84.9 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240
Week 192
|
85.1 percentage of participants
|
84.2 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240
Week 240
|
81.6 percentage of participants
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 96, 144, 192, and 240Population: Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
HBV DNA Level at Weeks 48, 96, 144, 192, and 240
Week 48 (TDF: n=130; FTC/TDF: n=133)
|
2.42 log10 copies/mL
Standard Deviation 0.542
|
2.48 log10 copies/mL
Standard Deviation 0.887
|
|
HBV DNA Level at Weeks 48, 96, 144, 192, and 240
Week 96 (TDF: n=132; FTC/TDF: n=127)
|
2.29 log10 copies/mL
Standard Deviation 0.254
|
2.28 log10 copies/mL
Standard Deviation 0.241
|
|
HBV DNA Level at Weeks 48, 96, 144, 192, and 240
Week 144 (TDF: n=128; FTC/TDF: n=123)
|
2.26 log10 copies/mL
Standard Deviation 0.173
|
2.29 log10 copies/mL
Standard Deviation 0.541
|
|
HBV DNA Level at Weeks 48, 96, 144, 192, and 240
Week 192 (TDF: n=126; FTC/TDF: n=119)
|
2.25 log10 copies/mL
Standard Deviation 0.135
|
2.23 log10 copies/mL
Standard Deviation 0.027
|
|
HBV DNA Level at Weeks 48, 96, 144, 192, and 240
Week 240 (TDF: n=118; FTC/TDF: n=116)
|
2.23 log10 copies/mL
Standard Deviation 0.052
|
2.26 log10 copies/mL
Standard Deviation 0.376
|
SECONDARY outcome
Timeframe: Weeks 48, 96, 144, 192, and 240Population: Full Analysis Set, missing = failure method
Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to \< 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240
Week 48
|
67.4 percentage of participants
|
69.8 percentage of participants
|
|
Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240
Week 96
|
70.2 percentage of participants
|
69.8 percentage of participants
|
|
Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240
Week 144
|
70.2 percentage of participants
|
75.5 percentage of participants
|
|
Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240
Week 192
|
75.9 percentage of participants
|
76.3 percentage of participants
|
|
Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240
Week 240
|
71.6 percentage of participants
|
71.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240Population: Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.
The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
Outcome measures
| Measure |
Tenofovir DF
n=65 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=68 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240
Week 48
|
9.2 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240
Week 96
|
15.4 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240
Week 144
|
23.1 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240
Week 192
|
21.5 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240
Week 240
|
24.6 percentage of participants
|
19.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240Population: Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.
The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.
Outcome measures
| Measure |
Tenofovir DF
n=65 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=68 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240
Week 48
|
6.2 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240
Week 96
|
10.8 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240
Week 144
|
12.3 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240
Week 192
|
10.8 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240
Week 240
|
12.3 percentage of participants
|
10.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240Population: Full Analysis Set, missing = failure method
The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240
Week 240
|
1.4 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240
Week 48
|
0.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240
Week 96
|
0.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240
Week 144
|
0.7 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240
Week 192
|
0.7 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240Population: Full Analysis Set, missing = failure method
The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240
Week 48
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240
Week 96
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240
Week 144
|
0.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240
Week 192
|
0.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240
Week 240
|
0.0 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240Population: Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.
The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being \< 400 copies/mL.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240
Week 144 (TDF: n=128; FTC/TDF: n=123)
|
0.8 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240
Week 192 (TDF: n=126; FTC/TDF: n=119)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240
Week 240 (TDF: n=118; FTC/TDF: n=116)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240
Week 48 (TDF: n=130; FTC/TDF: n=133)
|
0.0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240
Week 96 (TDF: n=132; FTC/TDF: n=127)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240Population: Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.
BMD is calculated as grams per cubic centimeter (g/cm\^2); the mean (SD) percentage change is presented.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 24 (TDF: n=132; FTC/TDF: n=127)
|
-1.74 percentage change
Standard Deviation 2.867
|
-1.83 percentage change
Standard Deviation 2.565
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 48 (TDF: n=126; FTC/TDF: n=121)
|
-1.68 percentage change
Standard Deviation 3.094
|
-1.73 percentage change
Standard Deviation 2.944
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 72 (TDF: n=123; FTC/TDF: n=119)
|
-1.35 percentage change
Standard Deviation 3.337
|
-1.95 percentage change
Standard Deviation 2.977
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 96 (TDF: n=126; FTC/TDF: n=114)
|
-1.24 percentage change
Standard Deviation 3.761
|
-1.72 percentage change
Standard Deviation 3.269
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 144 (TDF: n=123; FTC/TDF: n=110)
|
-1.36 percentage change
Standard Deviation 3.810
|
-1.63 percentage change
Standard Deviation 3.591
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 192 (TDF: n=120; FTC/TDF: n=106)
|
-1.32 percentage change
Standard Deviation 4.237
|
-1.60 percentage change
Standard Deviation 4.628
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 240 (TDF: n=115; FTC/TDF: n=102)
|
-0.83 percentage change
Standard Deviation 4.490
|
-1.15 percentage change
Standard Deviation 5.130
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240Population: Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.
BMD is calculated as g/cm\^2; the mean (SD) percentage change is presented.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 24 (TDF: n=130; FTC/TDF: n=127)
|
-0.71 percentage change
Standard Deviation 1.724
|
-0.59 percentage change
Standard Deviation 1.835
|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 48 (TDF: n=126; FTC/TDF: n=118)
|
-1.15 percentage change
Standard Deviation 2.120
|
-1.00 percentage change
Standard Deviation 2.063
|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 72 (TDF: n=121; FTC/TDF: n=115)
|
-1.59 percentage change
Standard Deviation 2.507
|
-1.61 percentage change
Standard Deviation 2.525
|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 96 (TDF: n=125; FTC/TDF: n=112)
|
-1.70 percentage change
Standard Deviation 2.617
|
-1.77 percentage change
Standard Deviation 2.801
|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 144 (TDF: n=120; FTC/TDF: n=107)
|
-2.02 percentage change
Standard Deviation 3.030
|
-1.91 percentage change
Standard Deviation 3.281
|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 192 (TDF: n=116; FTC/TDF: n=105)
|
-2.33 percentage change
Standard Deviation 3.190
|
-2.41 percentage change
Standard Deviation 3.783
|
|
Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
% Change at Week 240 (TDF: n=111; FTC/TDF: n=100)
|
-2.46 percentage change
Standard Deviation 3.191
|
-2.63 percentage change
Standard Deviation 3.872
|
SECONDARY outcome
Timeframe: Baseline to Week 240Population: Full Analysis Set
The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.
Outcome measures
| Measure |
Tenofovir DF
n=141 Participants
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 Participants
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Development of Drug-resistant Mutations (DRMs)
New tenofovir DF DRMs
|
0 participants
|
0 participants
|
|
Development of Drug-resistant Mutations (DRMs)
Enrichment of tenofovir DF DRMs
|
0 participants
|
0 participants
|
|
Development of Drug-resistant Mutations (DRMs)
New FTC DRMs
|
0 participants
|
0 participants
|
|
Development of Drug-resistant Mutations (DRMs)
Enrichment of FTC DRMs
|
0 participants
|
1 participants
|
Adverse Events
Tenofovir DF
Serious events: 23 serious events
Other events: 109 other events
Deaths: 0 deaths
FTC/Tenofovir DF
Serious events: 21 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenofovir DF
n=141 participants at risk
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 participants at risk
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.2%
3/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.4%
2/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.4%
2/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
2/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.71%
1/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.72%
1/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Tenofovir DF
n=141 participants at risk
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
|
FTC/Tenofovir DF
n=139 participants at risk
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
6/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.0%
7/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
8/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.6%
12/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
13/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.0%
7/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
12/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.9%
11/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
9.9%
14/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.8%
15/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.7%
8/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.6%
5/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
5.7%
8/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.2%
3/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
9.9%
14/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.2%
10/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
17.0%
24/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
14.4%
20/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Investigations
Creatinine renal clearance decreased
|
1.4%
2/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.0%
7/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
2/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.0%
7/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
10/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
12.9%
18/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
10/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.8%
15/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.5%
5/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.0%
7/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
7/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.8%
8/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
4/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.8%
8/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.0%
7/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.8%
8/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
16.3%
23/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
14.4%
20/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
12/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.4%
13/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.5%
12/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.2%
3/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.0%
7/141 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
9/139 • Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
Additional Information
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