Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

NCT ID: NCT02071082

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-25
• Study Completion Date: 2016-10-26

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

Conditions

HIV; HBV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

E/C/F/TAF

Intervention Type: DRUG

E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

HIV-suppressed

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

Group Type: EXPERIMENTAL

E/C/F/TAF

Intervention Type: DRUG

E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Interventions

E/C/F/TAF

E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Intervention Type: DRUG

Other Intervention Names

Genvoya®

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
• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Spectrum Medical Group

Phoenix, Arizona, United States

AHF Research Center

Beverly Hills, California, United States

Peter J. Ruane MD, Inc.

Los Angeles, California, United States

Anthony Mills MD, Inc

Los Angeles, California, United States

Whitman Walker Health

Washington D.C., District of Columbia, United States

Barry M. Rodwick MD

Clearwater, Florida, United States

Gary J Richmond M.D.,P.A.

Fort Lauderdale, Florida, United States

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

AIDS Health Foundation/WPA

Miami Beach, Florida, United States

AIDS Research and Treatment Center of the Treasure Coast

Vero Beach, Florida, United States

Triple O Research Institute PA

West Palm Beach, Florida, United States

Be Well Medical Center PC

Berkley, Michigan, United States

KC Care Clinic

Kansas City, Missouri, United States

Southampton Healthcare, Inc.

St Louis, Missouri, United States

Southwest CARE Center

Santa Fe, New Mexico, United States

Central Texas Clinical Research

Austin, Texas, United States

St. Hope Foundation

Bellaire, Texas, United States

North Texas Infectious Diseases Consultants

Dallas, Texas, United States

Therapeutic Concepts

Houston, Texas, United States

Gordon E. Crofoot MD PA

Houston, Texas, United States

Peter Shalit MD

Seattle, Washington, United States

University Health Network/Toronto General Hospital

Toronto, Ontario, Canada

Maple Leaf Research/Maple Leaf Medical Clinic

Toronto, Ontario, Canada

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, Japan

Countries

United States; Canada; Japan

Other Identifiers

GS-US-292-1249

Identifier Type: -

Identifier Source: org_study_id