The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
Institute of Human Virology Clinical Research Unit
Baltimore, Maryland, United States
Newlands Health
Philadelphia, Pennsylvania, United States
HIV-1 RNA at Week 24
Proportion of participants with HIV-1 RNA \<50 copies/mL at Week 24 by US FDA Snapshot Algorithm
Time frame: Week 24
HBV DNA at Week 24
Proportion of participants with plasma HBV DNA \<29 IU/mL at Week 24 as defined by Missing=Failure Approach
Time frame: Week 24
HIV-1 RNA at Week 48
Proportion of participants with HIV-1 RNA \<50 copies/mL at Week 48 by US FDA Snapshot Algorithm
Time frame: Week 48
HBV DNA at Week 48
Proportion of participants with plasma HBV DNA \<29 IU/mL at Week 48 as defined by Missing=Failure Approach
Time frame: Week 48
CD4 Cell Count Change at Week 24
Change from baseline in CD4 cell count at Week 24
Time frame: Baseline; Week 24
CD4 Cell Count Change at Week 48
Change from baseline in CD4 cell count at Week 48
Time frame: Baseline; Week 48
ALT Normalization at Week 24
Proportion of participants with normal ALT at Week 24
Time frame: Week 24
ALT Normalization at Week 48
Proportion of participants with normal ALT at Week 48
Time frame: Week 48
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HBeAg Loss at Week 48
Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.
Time frame: Week 48
HBsAg Loss at Week 48
Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.
Time frame: Week 48