Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
Condition: HIV-1/HBV Co-Infection
MeSH terms: Hepatitis B; Coinfection
Intervention: B/F/TAF; Placebo to match DTG; Placebo to match F/TDF; DTG; F/TDF; Placebo to match B/F/TAF
Intervention description: 50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food; Tablet administered orally once daily, without regard to food; Tablet administered orally once daily, without regard to food; 50 mg tablet administered orally once daily, without regard to food; 200/300 mg tablet administered orally once daily, without regard to food; Tablet administered orally once daily, without regard to food
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of fixed-dose combination
      (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG)
      + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV)
      treatment naive, HIV-1 and HBV co-infected adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HIV-1 co-infection:

               -  Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA ≥ 500 copies/mL
                  at screening

               -  ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine
                  and entecavir, following a diagnosis of HIV-1 infection (except the use for
                  pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one
                  month prior to screening)

               -  Screening genotype report must show sensitivity to emtricitabine (FTC) and
                  tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively,
                  if genotype results from a local laboratory obtained ≤ 90 days prior to screening
                  visit date show sensitivity to these drugs, this genotype will be acceptable to
                  fulfill this inclusion criterion in the event that the genotype obtained at
                  screening is not yet available and all other inclusion/exclusion criteria have
                  been confirmed

          -  HBV co-infection:

               -  Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)

               -  Screening HBV DNA ≥ 2000 IU/mL

          -  Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of
             normal (ULN)

          -  Total bilirubin ≤ 2.5 x ULN

        Key Exclusion Criteria:

          -  Hepatitis C virus (HCV) antibody positive and HCV RNA detectable

          -  Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
             variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with study compliance

          -  Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to Day 1

          -  Participation in any other clinical trial, including observational studies, without
             prior approval from the sponsor is prohibited while participating in this trial

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.