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

NCT02071082 | Completed Phase 3 Results DMC

• 1 other identifier: GS-US-292-1249
• Study Type: interventional
• Target: 79
• Locations: 3 countries
• Sites: 24

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

Keywords

HIV; HBV; Coinfection

Outcome Measures

Primary Outcomes (2)

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

  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.

  Week 24

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

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

  Week 24

Secondary Outcomes (10)

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

  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 Normalized ALT at Week 48

  Baseline; Week 48

• Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24

  Baseline; Week 24

Study Arms (2)

HIV treatment-naive and HBV treatment-naive

EXPERIMENTAL

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

Drug: E/C/F/TAF

HIV-suppressed

EXPERIMENTAL

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

Drug: E/C/F/TAF

Interventions

E/C/F/TAF DRUG

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

Also known as: Genvoya®

HIV treatment-naive and HBV treatment-naive; HIV-suppressed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (24)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

AHF Research Center

Beverly Hills, California, 90211, United States

Location

Peter J. Ruane MD, Inc.

Los Angeles, California, 90036, United States

Location

Anthony Mills MD, Inc

Los Angeles, California, 90069, United States

Location

Whitman Walker Health

Washington D.C., District of Columbia, 20009, United States

Location

Barry M. Rodwick MD

Clearwater, Florida, 33765, United States

Location

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

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

AIDS Health Foundation/WPA

Miami Beach, Florida, 33139, United States

Location

AIDS Research and Treatment Center of the Treasure Coast

Vero Beach, Florida, 32960, United States

Location

Triple O Research Institute PA

West Palm Beach, Florida, 33401, United States

Location

Be Well Medical Center PC

Berkley, Michigan, 48072, United States

Location

KC Care Clinic

Kansas City, Missouri, 64111, United States

Location

Southampton Healthcare, Inc.

St Louis, Missouri, 63139, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

St. Hope Foundation

Bellaire, Texas, United States

Location

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States

Location

Therapeutic Concepts

Houston, Texas, 77004, United States

Location

Gordon E. Crofoot MD PA

Houston, Texas, 77098, United States

Location

Peter Shalit MD

Seattle, Washington, 98104, United States

Location

University Health Network/Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Maple Leaf Research/Maple Leaf Medical Clinic

Toronto, Ontario, M5G1K2, Canada

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, 1628655, Japan

Location

MeSH Terms

Conditions

Coinfection

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 25, 2014
• Primary Completion: January 23, 2015
• Study Completion: October 26, 2016
• Last Updated: November 16, 2018
• Results First Posted: April 4, 2016

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (21); JP (1); CA (2)