Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

February 18, 2020 updated by: Gilead Sciences

A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection

This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Auckland Clinical Studies
      • Christchurch, New Zealand
        • Christchurch Clinical Studies Trust
  • Puerto Rico
      • San Juan, Puerto Rico
        • Fundacion De Investigacion de Diego
  • United States
    • California
      • Los Angeles, California, United States
        • Cedars Sinai Medical Center
      • Palo Alto, California, United States
        • Stanford University
      • Pasadena, California, United States
        • Huntington Memorial Hospital Liver Center
      • San Diego, California, United States
        • Medical Associates Research Group, Inc.
    • Colorado
      • Denver, Colorado, United States
        • University of Colorado
    • Florida
      • Jacksonville, Florida, United States
        • Borland-Groover Clinic
      • Miami, Florida, United States
        • University of Miami
      • Orlando, Florida, United States
        • Orlando Immunology Center
      • Wellington, Florida, United States
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, United States
        • Center for Hep C/Atlanta Medical Center
      • Marietta, Georgia, United States
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University
      • Indianapolis, Indiana, United States
        • Indianapolis Gastroenterology & Hepatology, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States
        • Beth Isreal Deconess Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital and Health System
    • New Jersey
      • Hillsborough, New Jersey, United States
        • ID care
    • New Mexico
      • Santa Fe, New Mexico, United States
        • Southwest CARE Center
    • New York
      • Manhasset, New York, United States
        • North Shore/Long Island Jewish PRIME
      • New York, New York, United States
        • Mount Sinai Beth Israel
    • North Carolina
      • Fayetteville, North Carolina, United States
        • Cumberland Research Associates, LLC
      • Winston-Salem, North Carolina, United States
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania Health Systems
      • Pittsburgh, Pennsylvania, United States
        • UPMC Center for Liver Diseases
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Tennessee
      • Germantown, Tennessee, United States
        • Gastro One
      • Nashville, Tennessee, United States
        • Nashville Gastrointestinal Specialists, Inc.
    • Texas
      • San Antonio, Texas, United States
        • Texas Liver Institute
    • Virginia
      • Richmond, Virginia, United States
        • Liver Institute of Virginia
    • Washington
      • Seattle, Washington, United States
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Individuals with chronic HCV infection
  • HCV RNA ≥10^4 IU/mL at screening
  • HCV genotype 1
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

  • Pregnant or nursing female
  • Current or prior history of hepatic decompensation
  • Hepatocellular carcinoma (HCC) or other clinically significant malignancy
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
Drug: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
  • GS-9857
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 12 Weeks
Up to 12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time Frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Time Frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure
Time Frame: Up to Posttreatment Week 24

  • On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Up to Posttreatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 12, 2016

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-367-1168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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