B/F/TAF Switch Study for HIV-HBV Coinfection
Condition: HIV-1-infection; Hepatitis B
MeSH terms: Hepatitis B; Coinfection; Hepatitis
Intervention: B/F/TAF
Intervention description: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection.
Masking: None (Open Label)
Masking description: This is an open label study
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; Hepatitis B; HIV-HBV coinfection; Bictegravir; B/F/TAF; Tenofovir alafenamide; Biktarvy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older at enrollment.

          2. Documented HIV-1 infection and currently on a stable regimen for at least 3 months if
             on an INSTI-based regimen (6 months if on a non-INSTI-based regimen) preceding the
             screening visit with documented plasma HIV-1 RNA ≤ 50 copies/mL for at least 3 months
             preceding the screening visit.

          3. No known history of resistance to tenofovir alafenamide (TAF), emtricitabine (FTC), or
             Bictegravir (BIC).

          4. Documented chronic hepatitis B infection, based on any of the following: a. Positive
             HBsAg result or nucleic acid test for HBV DNA (including qualitative, quantitative,
             and genotype testing) or positive HBeAg on two occasions at least 6 months apart (any
             combination of these tests performed 6 months apart is acceptable); or b. Negative
             immunoglobulin M (IgM) antibodies to HBV core antigen (anti-HBc IgM) AND a positive
             results on one of the following tests: HBsAg, HBeAg, or nucleic acid test for HBV DNA
             (including qualitative, quantitative, and genotype testing) prior to or at screening.

          5. No current or prior regimen containing three active anti-HBV agents (i.e. cannot be on
             tenofovir alafenamide (TDF)/emtricitabine (FTC)/entecavir or TDF/lamivudine
             (3TC)/entecavir).

          6. Must have a primary care provider(s) for medical management.

          7. Females of childbearing potential must agree to utilize protocol recommended highly
             effective contraceptive methods or be non-heterosexually active or practice sexual
             abstinence from screening and throughout the duration of the study. Female subjects
             who utilize hormonal contraceptive as one of their birth control methods must have
             used the same method for at least 3 months prior to study drug dosing.

          8. Male subjects must be willing to abstain from heterosexual intercourse or use a condom
             throughout the study period.

          9. Stated willingness to comply with all study procedures and availability for the
             duration of the study.

         10. Written informed consent must be obtained before any study procedure is performed.

        Exclusion Criteria:

          1. Females who are pregnant or breastfeeding.

          2. Any known allergies to any of the components of B/F/TAF.

          3. Treatment with another investigational drug within three months of enrollment.

          4. Abnormal hematological and biochemical parameters at screening, including:

               1. Absolute neutrophil count (ANC) < 750 cells/mm3.

               2. Platelets < 50,000/mm3.

               3. Hemoglobin < 8.5 g/dL.

               4. AST or ALT of > 5 times upper limit of normal (ULN).

               5. Estimated GFR < 30 mL/min/1.73 m2.

               6. Total bilirubin > 1.5 times ULN.

          5. Previous or current history of malignancy, other than cutaneous Kaposi's sarcoma,
             basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma.
             Note: Those with a history of malignancy who are in remission for two or more years
             may be included in the study.

          6. An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening.

          7. Subjects experiencing decompensated cirrhosis (e.g. ascites, encephalopathy, or
             variceal bleeding).

          8. Acute hepatitis in the 30 days prior to study entry.

          9. Active tuberculosis infection.

         10. Subjects receiving ongoing therapy with any medications contraindicated for
             co-administration with B/F/TAF FDC, including but not limited to the following
             medications: dofetilide, phenobarbital, phenytoin, carbamazepine, oxcarbamazepine,
             rifampin, rifapentine, cisapride, St. John's Wort, and Echinaceae.

         11. Current alcohol or substance use that in the opinion of the investigator may interfere
             with subject study compliance.

         12. Any other clinical conditions that in the opinion of the investigator would make the
             subject unsuitable for the study or unable to comply with the dosing requirements.