Trial Outcomes & Findings for Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults (NCT NCT02071082)
NCT ID: NCT02071082
Last Updated: 2018-11-16
Results Overview
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
79 participants
Primary outcome timeframe
Week 24
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in North America and Japan. The first participant was screened on 25 February 2014. The last study visit occurred on 26 October 2016.
113 participants were screened.
Participant milestones
| Measure |
HIV/HBV Treatment-Naive (Cohort 1)
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
|
HIV-Suppressed (Cohort 2)
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
75
|
|
Overall Study
COMPLETED
|
2
|
68
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
HIV/HBV Treatment-Naive (Cohort 1)
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
|
HIV-Suppressed (Cohort 2)
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Overall Study
Enrolled and Never Treated
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
Baseline characteristics by cohort
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=74 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
49 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
49 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=5 Participants
|
50 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 participants
n=5 Participants
|
62 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
62 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
HIV-1 RNA
|
4.20 log10 copies/mL
STANDARD_DEVIATION 1.242 • n=5 Participants
|
1.29 log10 copies/mL
STANDARD_DEVIATION 0.068 • n=7 Participants
|
1.41 log10 copies/mL
STANDARD_DEVIATION 0.606 • n=5 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
0 participants
n=5 Participants
|
73 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
HBV DNA
|
8.31 log10 IU/mL
STANDARD_DEVIATION 0.416 • n=5 Participants
|
1.49 log10 IU/mL
STANDARD_DEVIATION 0.883 • n=7 Participants
|
1.75 log10 IU/mL
STANDARD_DEVIATION 1.588 • n=5 Participants
|
|
HBV DNA Category
< 29 IU/mL
|
0 participants
n=5 Participants
|
64 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
HBV DNA Category
≥ 29 IU/mL
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Alanine Aminotransferase (ALT)
|
84 U/L
STANDARD_DEVIATION 38.9 • n=5 Participants
|
31 U/L
STANDARD_DEVIATION 21.1 • n=7 Participants
|
33 U/L
STANDARD_DEVIATION 23.9 • n=5 Participants
|
|
Hepatitis B Surface Antigen Status
Positive
|
3 participants
n=5 Participants
|
71 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Hepatitis B Surface Antigen Status
Negative
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Hepatitis B e-Antibody Status
Positive
|
0 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Hepatitis B e-Antibody Status
Negative
|
3 participants
n=5 Participants
|
43 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Hepatitis B e-Antibody Status
Borderline
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Fibrotest® Score
|
0.27 units on a scale
n=5 Participants
|
0.35 units on a scale
n=7 Participants
|
0.34 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, had at least 1 post-Day 1 plasma HBV DNA or HIV-1 RNA result while on study, and had no major protocol violations from the eligibility criteria.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=72 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
|
100.0 percentage of participants
|
94.4 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis set
The percentage of participants with HBV DNA \< 29 IU/mL at Week 24 was calculated using the missing = failure method.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=72 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
|
33.3 percentage of participants
|
86.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=72 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
|
66.7 percentage of participants
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set
The percentage of participants with HBV DNA \< 29 IU/mL at Week 48 was calculated using the missing = failure method.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=72 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
|
66.7 percentage of participants
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=10 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24
|
100.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=10 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 48
|
66.7 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=70 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24
|
0 percentage of participants
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=70 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to Anti-HBs at Week 48
|
0 percentage of participants
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=30 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24
|
33.3 percentage of participants
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=30 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to Anti-HBe at Week 48
|
33.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=3 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=67 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Change From Baseline in FibroTest® Score at Week 24
|
-0.19 units on a scale
Interval -0.24 to -0.1
|
-0.02 units on a scale
Interval -0.12 to 0.04
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Outcome measures
| Measure |
HIV/HBV Treatment-Naive
n=2 Participants
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
HIV-Suppressed
n=67 Participants
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
|
|---|---|---|
|
Change From Baseline in FibroTest® Score at Week 48
|
-0.15 units on a scale
Interval -0.21 to -0.08
|
-0.07 units on a scale
Interval -0.12 to 0.02
|
Adverse Events
HIV/HBV Treatment-Naive
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
HIV-Suppressed
Serious events: 12 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV/HBV Treatment-Naive
n=3 participants at risk
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
|
HIV-Suppressed
n=74 participants at risk
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
HIV/HBV Treatment-Naive
n=3 participants at risk
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
|
HIV-Suppressed
n=74 participants at risk
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
|
|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
0.00%
0/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
10.8%
8/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
9.5%
7/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
2.7%
2/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
8.1%
6/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
1.4%
1/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
12.2%
9/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
6.8%
5/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
4.1%
3/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
23.0%
17/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
8.1%
6/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
5.4%
4/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
6.8%
5/74 • Up to 126 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER