efficacy and safety of e/c/f/taf (genvoya®) in hiv-1/hepatitis b co-infected adults

Conditions: HIV; HBV

Summary: this study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) fixed-dose combination (fdc) in human immunodeficiency virus (hiv)/hepatitis b virus (hbv) coinfected adults. participants will be enrolled into two cohorts: * cohort 1: hiv/hbv coinfected adults who are hiv treatment-naive and hbv treatment-naive * cohort 2: hiv/hbv coinfected adults who are 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.

Keywords: hiv hbv coinfection