Intervention: Racivir
Trial phase: Phase 3
ATC code: J05AF09 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR17 | J05AR18 | J05AR19 | J05AR20 | J05AR22
SMILES: Nc1nc(=O)n(C2CSC(CO)O2)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
Eligibility criteria:
Key Inclusion Criteria:

Both Cohorts 1 and 2:

The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
HIV/HBV co-infected adult males and non-pregnant and non-lactating females

No evidence of hepatocellular carcinoma (HCC) or clinical or imaging evidence of cirrhosis (ascites, variceal bleeding, encephalopathy).

--- Subjects should have documentation of an abdominal ultrasound in the 12 months prior to screening, or an abdominal ultrasound at screening, demonstrating the absence of cirrhosis and HCC.

Acute Hepatitis A virus (HAV) immunoglobulin M (IgM) negative
Hepatitis C virus (HCV) Ab negative, or HCV Ab positive with negative HCV RNA
Hepatitis D virus (HDV) Ab negative, or HDV Ab positive with negative HDV RNA
Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula
CD4+ count of > 200 cells/μL

Chronic HBV infection as defined by

HBsAg positive for ≥ 6 months Or
HBsAg positive at screening and either hepatitis B e antigen (HBeAg) or HBV DNA positive ≥ 6 months Or

At screening: positive total hepatitis B core antibody (HBcAb) and negative immunoglobulin M antibody to hepatitis B core antigen (HBcIgM) antibody, and

HBsAg positive, or
HBeAg positive, or
HBV DNA positive

Cohort 1 (HIV and HBV treatment naive) only:

No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (PrEP), or post exposure prophylaxis (PEP)
No current or prior anti-HBV treatment
Plasma HIV-1 RNA level ≥ 500 copies/mL at screening
Screening HBV DNA ≥ 3 log10 IU/mL and < 9 log10 IU/mL

Cohort 2 (HIV suppressed) only:

Receiving current antiretroviral regimen for at least 4 consecutive months
No current or prior regimen containing 3 active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/Entecavir or TDF/lamivudine(3TC)/Entecavir)
Maintained plasma HIV-1 RNA < 50 copies/mL for 6 consecutive months prior to and at the time of the screening visit. Unconfirmed virologic evaluation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
Documented positive HIV antibody test
Screening HBV DNA < 9 log10 IU/mL

Key Exclusion Criteria:

Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Have an implanted defibrillator or pacemaker
Current alcohol or substance use
A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive carcinoma.
Received solid organ or bone marrow transplant
Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses), or multiple bone fractures
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone)
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.