Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)

May 8, 2014 updated by: Gilead Sciences

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 3

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

  • Australia
      • Melbourne, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Australia, 3065
        • St. Vincent's Hospital
    • New South Wales
      • Westmead,, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • CHUM - The Research Centre
  • New Zealand
      • Auckland, New Zealand, 1640
        • Auckland Clinical Studies Limited
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico Inc
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2170
        • University of Alabama Birmingham
    • California
      • Coronado, California, United States, 92118
        • SCTI Research Foundation Liver Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
      • Los Angeles, California, United States, 90069
        • Anthony Mills MD, Inc.
      • Los Angeles, California, United States, 90036
        • Lightspeed Medical
      • San Diego, California, United States, 92103
        • UCSD Antiviral Research Center
      • San Diego, California, United States, 92154
        • Kaiser Permanente
      • San Diego, California, United States, 912123
        • Medical Associates Research Group
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic
    • Florida
      • Gainesville, Florida, United States, 32610-0277
        • University of Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Miami, Florida, United States, 33136
        • University of Miami, Center for Liver Diseases
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, United States, 32803-1851
        • Orlando Immunology Center (ACH)
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2696
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • Minnesota
      • St. Paul, Minnesota, United States, 55407
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
      • Hillsborough, New Jersey, United States, 08844
        • ID Care
    • New York
      • Binghamton, New York, United States, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Dallas, Texas, United States, 75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, PA
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Newport News, Virginia, United States, 23602
        • Liver Institute of Virginia, Bon Secours St.Mary's
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason 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

Inclusion Criteria:

  • Infection with HCV genotype 2 or 3
  • Cirrhosis determination

  • Subject meets one of the following classifications:

    1. IFN unwilling
    2. IFN ineligible
    3. IFN intolerant
  • Screening laboratory values within defined thresholds
  • Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF+RBV
Participants were randomized to receive SOF+RBV for 12 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo Comparator: Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
Drug: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Drug: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving SVR12
Time Frame: Post-treatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy
Post-treatment Week 12
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Time Frame: Baseline to Week 12
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving SVR4
Time Frame: Post-treatment Week 4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Post-treatment Week 4
Percentage of Participants Achieving SVR24
Time Frame: Post-treatment Week 24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Post-treatment Week 24
Percentage of Participants Experiencing Viral Breakthrough
Time Frame: Baseline to Week 12
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values
Baseline to Week 12
Percentage of Participants Experiencing Viral Relapse
Time Frame: End of treatment to post-treatment Week 24
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
End of treatment to post-treatment 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

March 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0107

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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