A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults

Gilead Sciences24 sites in 3 countries79 target enrollmentFebruary 25, 2014

ConditionsHIV HBV

InterventionsE/C/F/TAF

DrugsE/C/F/TAF

Overview

Phase: Phase 3
Intervention: E/C/F/TAF
Conditions: HIV
Sponsor: Gilead Sciences
Enrollment: 79
Locations: 24
Primary Endpoint: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 25, 2014

End Date

October 26, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

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

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)

Arms & Interventions

HIV treatment-naive and HBV treatment-naive

HIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks.

Intervention: E/C/F/TAF

HIV-suppressed

HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.

Intervention: E/C/F/TAF

Outcomes

Primary Outcomes

Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL

Time Frame: Week 24

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL

Time Frame: Week 24

The percentage of participants with HBV DNA \< 29 IU/mL at Week 24 was calculated using the missing = failure method.

Secondary Outcomes

Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL(Week 48)
Percentage of Participants With Normalized ALT at Week 48(Baseline; Week 48)
Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24(Baseline; Week 24)
Percentage of Participants With Seroconversion to Anti-HBe at Week 48(Baseline; Week 48)
Change From Baseline in FibroTest® Score at Week 24(Baseline; Week 24)
Change From Baseline in FibroTest® Score at Week 48(Baseline; Week 48)
Percentage of Participants With Seroconversion to Anti-HBs at Week 48(Baseline; Week 48)
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL(Week 48)
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24(Baseline; Week 24)
Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24(Baseline; Week 24)