Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults (NCT02071082) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
United States79 participantsStarted 2014-02-25
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 an…
What they're measuring
1
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Timeframe: Week 24
2
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL