Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated (NCT NCT02579382)
NCT ID: NCT02579382
Last Updated: 2020-05-18
Results Overview
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (\> 19 vs ≤ 19 IU/L for females; \> 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Baseline; Week 24
Results posted on
2020-05-18
Participant Flow
Participants were enrolled at study sites in Asia, Europe, New Zealand, and North America. The first participant was screened on 10 November 2015. The last study visit occurred on 03 May 2019.
260 participants were screened
Participant milestones
| Measure |
TDF + Placebo
Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 1 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 2 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
|---|---|---|---|---|
|
Main Study Phase
STARTED
|
28
|
53
|
56
|
55
|
|
Main Study Phase
COMPLETED
|
28
|
53
|
54
|
52
|
|
Main Study Phase
NOT COMPLETED
|
0
|
0
|
2
|
3
|
|
Optional Treatment Extension Phase(OTEP)
STARTED
|
27
|
51
|
54
|
49
|
|
Optional Treatment Extension Phase(OTEP)
COMPLETED
|
26
|
44
|
50
|
44
|
|
Optional Treatment Extension Phase(OTEP)
NOT COMPLETED
|
1
|
7
|
4
|
5
|
Reasons for withdrawal
| Measure |
TDF + Placebo
Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 1 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 2 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
|---|---|---|---|---|
|
Main Study Phase
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Main Study Phase
Withdrew Consent
|
0
|
0
|
0
|
2
|
|
Main Study Phase
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Optional Treatment Extension Phase(OTEP)
Withdrew Consent
|
0
|
3
|
1
|
4
|
|
Optional Treatment Extension Phase(OTEP)
Investigator's discretion
|
1
|
0
|
2
|
0
|
|
Optional Treatment Extension Phase(OTEP)
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Optional Treatment Extension Phase(OTEP)
Adverse Event
|
0
|
1
|
0
|
0
|
|
Optional Treatment Extension Phase(OTEP)
Pregnancy
|
0
|
1
|
0
|
0
|
|
Optional Treatment Extension Phase(OTEP)
Non-compliance with Study Drug
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
Baseline characteristics by cohort
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
41 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
44 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
44 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
42 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
22 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
192 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
4 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
17 participants
n=5 Participants
|
15 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Region of Enrollment
Hong Kong
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
10 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Serum Hepatitis B Surface Antigen (HBsAg) (log10 IU/mL)
|
3.8 log10 IU/mL
STANDARD_DEVIATION 0.84 • n=5 Participants
|
3.7 log10 IU/mL
STANDARD_DEVIATION 0.84 • n=7 Participants
|
3.5 log10 IU/mL
STANDARD_DEVIATION 0.88 • n=5 Participants
|
3.6 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=4 Participants
|
3.6 log10 IU/mL
STANDARD_DEVIATION 0.82 • n=21 Participants
|
|
Hepatitis B Envelope Antigen (HBeAg) Status
HBeAg Status- Negative
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Hepatitis B Envelope Antigen (HBeAg) Status
HBeAg Status- Positive
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Hepatitis B Virus (HBV) DNA
|
5.9 log10 IU/mL
STANDARD_DEVIATION 2.10 • n=5 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 1.80 • n=7 Participants
|
5.6 log10 IU/mL
STANDARD_DEVIATION 1.85 • n=5 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 1.70 • n=4 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 1.82 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 24Population: The Full Analysis Set included all participants who were randomized and took at least 1 dose of study drug.
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (\> 19 vs ≤ 19 IU/L for females; \> 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=54 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=54 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
|
-0.163 log10 IU/mL
Interval -0.305 to -0.022
|
-0.056 log10 IU/mL
Interval -0.159 to 0.047
|
-0.146 log10 IU/mL
Interval -0.246 to -0.045
|
-0.036 log10 IU/mL
Interval -0.138 to 0.065
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative Hepatitis B Envelope Antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Outcome measures
| Measure |
TDF + Placebo
n=11 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=20 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=23 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=21 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Outcome measures
| Measure |
TDF + Placebo
n=11 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=20 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=23 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=21 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
|
0 percentage of participants
|
5.0 percentage of participants
|
4.3 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set who were HBsAg positive at baseline were analyzed.
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative Hepatitis B Surface Antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set who were HBsAg positive at baseline were analyzed.
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TDF + Placebo
n=27 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=52 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
|
-0.087 log10 IU/mL
Standard Deviation 0.2199
|
-0.041 log10 IU/mL
Standard Deviation 0.2283
|
-0.138 log10 IU/mL
Standard Deviation 0.5247
|
-0.020 log10 IU/mL
Standard Deviation 0.2668
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=54 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
|
-0.338 log10 IU/mL
Standard Deviation 0.8922
|
-0.079 log10 IU/mL
Standard Deviation 0.2912
|
-0.197 log10 IU/mL
Standard Deviation 0.5757
|
-0.088 log10 IU/mL
Standard Deviation 0.3700
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set were analyzed.
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
|
7.1 percentage of participants
|
3.8 percentage of participants
|
10.7 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set were analyzed.
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 24 post-baseline visit.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
|
10.7 percentage of participants
|
3.8 percentage of participants
|
10.7 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set were analyzed.
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
|
17.9 percentage of participants
|
5.7 percentage of participants
|
16.1 percentage of participants
|
14.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set were analyzed.
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
|
53.6 percentage of participants
|
58.5 percentage of participants
|
59.3 percentage of participants
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants With HBV DNA < LLOQ at Week 48
|
64.3 percentage of participants
|
62.3 percentage of participants
|
75.9 percentage of participants
|
75.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: Participants in the Full Analysis Set were analyzed.
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having had HBV DNA \< 69 IU/mL or confirmed 1.0 log10 IU/mL or greater increase in HBV DNA from nadir. Confirmation requires 2 consecutive occurrences of elevation in HBV DNA to \> 69 IU/mL after having had HBV DNA \< 69 IU/mL or 1.0 log10 IU/mL or greater increases in HBV DNA from nadir.
Outcome measures
| Measure |
TDF + Placebo
n=28 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Virologic Breakthrough
Week 48
|
0 percentage of participants
|
3.8 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Virologic Breakthrough
Week 24
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Sequence analysis of the HBV pol/RT was attempted for any participant who had HBV DNA ≥ 69 IU/mL at Week 48 or early discontinuation. Results of the alignment of Week 48 and baseline sequence were reported as a change from baseline sequence.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=13 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=7 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: The PK Substudy Analysis Set included all randomized participants who took at least 1 dose of vesatolimod, participated in the PK substudy, and had at least 1 non-missing steady state PK parameter.
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
|
5252.3 hour*picogram/milliliter (h*pg/mL)
Standard Deviation 5756.26
|
7170.6 hour*picogram/milliliter (h*pg/mL)
Standard Deviation 4569.83
|
28537.2 hour*picogram/milliliter (h*pg/mL)
Standard Deviation 23608.94
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set with available data were analyzed.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: AUCinf of Vesatolimod
|
7277.3 h*pg/mL
Standard Deviation 6550.71
|
10239.0 h*pg/mL
Standard Deviation 6243.75
|
34534.8 h*pg/mL
Standard Deviation 26482.89
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: %AUCexp of Vesatolimod
|
31.1 Percentage of AUC
Standard Deviation 19.70
|
28.6 Percentage of AUC
Standard Deviation 11.42
|
19.3 Percentage of AUC
Standard Deviation 6.15
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: Cmax of Vesatolimod
|
667.8 picogram/milliliter (pg/mL)
Standard Deviation 785.44
|
850.4 picogram/milliliter (pg/mL)
Standard Deviation 569.75
|
4957.5 picogram/milliliter (pg/mL)
Standard Deviation 5035.46
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
Clast is defined as the last observable concentration of drug.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: Clast of Vesatolimod
|
92.8 pg/mL
Standard Deviation 73.80
|
119.0 pg/mL
Standard Deviation 74.45
|
328.0 pg/mL
Standard Deviation 165.19
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
Tmax is defined as the time (observed time point) of Cmax
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: Tmax of Vesatolimod
|
1.00 hours
Interval 0.47 to 4.0
|
2.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
Tlast is defined as the time (observed time point) of Clast.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: Tlast of Vesatolimod
|
24.00 hours
Interval 8.0 to 24.0
|
24.00 hours
Interval 24.0 to 24.0
|
24.00 hours
Interval 24.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: T1/2 of Vesatolimod
|
10.79 hours
Interval 4.57 to 50.08
|
14.12 hours
Interval 12.32 to 26.49
|
13.32 hours
Interval 8.9 to 14.83
|
—
|
SECONDARY outcome
Timeframe: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdosePopulation: Participants in the PK Substudy Analysis Set were analyzed.
CL/F is defined as the apparent oral clearance following administration of the drug.
Outcome measures
| Measure |
TDF + Placebo
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=5 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=4 Participants
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
|---|---|---|---|---|
|
PK Parameter: CL/F of Vesatolimod
|
273.9 liter/hour
Standard Deviation 270.58
|
262.3 liter/hour
Standard Deviation 144.45
|
156.2 liter/hour
Standard Deviation 72.48
|
—
|
Adverse Events
TDF + Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
TDF + Vesatolimod 1 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
TDF + Vesatolimod 2 mg
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
TDF + Vesatolimod 4 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
TDF Extension From TDF + Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
TDF Extension From TDF + Vesatolimod 1 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
TDF Extension From TDF + Vesatolimod 2 mg
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
TDF Extension From TDF + Vesatolimod 4 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDF + Placebo
n=28 participants at risk
Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 participants at risk
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod (GS 9620) 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 participants at risk
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 participants at risk
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF Extension From TDF + Placebo
n=27 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; Includes participants who received TDF + Placebo in the Main Study Phase.
|
TDF Extension From TDF + Vesatolimod 1 mg
n=51 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 1 mg in the Main Study Phase.
|
TDF Extension From TDF + Vesatolimod 2 mg
n=54 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 2 mg in the Main Study Phase.
|
TDF Extension From TDF + Vesatolimod 4 mg
n=49 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 4 mg in the Main Study Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic congestion
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
TDF + Placebo
n=28 participants at risk
Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 1 mg
n=53 participants at risk
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod (GS 9620) 1 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 2 mg
n=56 participants at risk
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF + Vesatolimod 4 mg
n=55 participants at risk
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
|
TDF Extension From TDF + Placebo
n=27 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; Includes participants who received TDF + Placebo in the Main Study Phase.
|
TDF Extension From TDF + Vesatolimod 1 mg
n=51 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 1 mg in the Main Study Phase.
|
TDF Extension From TDF + Vesatolimod 2 mg
n=54 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 2 mg in the Main Study Phase.
|
TDF Extension From TDF + Vesatolimod 4 mg
n=49 participants at risk
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 4 mg in the Main Study Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
2/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.1%
2/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
2/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
4/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
2/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
5/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.4%
3/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.4%
5/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.4%
3/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
5/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
2/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
2/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
5/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
7.1%
2/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
2/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.5%
3/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chills
|
3.6%
1/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
2/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
6/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
18.2%
10/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
21.4%
6/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.1%
8/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
6/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.5%
14/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.1%
2/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
3.6%
1/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
5/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
4/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
8.9%
5/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
11/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Gingivitis
|
7.1%
2/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
3/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
2/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
2/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.8%
5/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
3/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.3%
4/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.4%
2/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.9%
3/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.4%
4/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.1%
2/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.4%
3/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.4%
3/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
18.2%
10/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
2/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
4/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
2/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.4%
2/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.7%
3/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.4%
5/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
4/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
16.4%
9/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
2/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.4%
3/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
5/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
4/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.9%
10/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
21.8%
12/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.0%
1/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
2/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.4%
2/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
2/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.9%
1/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.1%
3/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
1/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.4%
5/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
2/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.7%
3/53 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.8%
1/56 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
2/55 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/51 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/54 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/49 • First dose date up to last dose of study drug (Maximum: 144 weeks)
The Safety Analysis Set included all participants who took 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