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

NCT ID: NCT01542788

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-02-28

Brief Summary

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.

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SOF+RBV

Participants were randomized to receive SOF+RBV for 12 weeks.

Group Type: EXPERIMENTAL

SOF

Intervention Type: DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBV

Intervention Type: DRUG

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

Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo to match SOF

Intervention Type: DRUG

Placebo to match SOF was administered orally once daily.

Placebo to match RBV

Intervention Type: DRUG

Placebo to match RBV was administered orally twice daily.

Interventions

SOF

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Intervention Type: 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).

Intervention Type: DRUG

Placebo to match SOF

Placebo to match SOF was administered orally once daily.

Intervention Type: DRUG

Placebo to match RBV

Placebo to match RBV was administered orally twice daily.

Intervention Type: DRUG

Other Intervention Names

Sovaldi®; GS-7977; PSI-7977

Eligibility Criteria

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

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

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

SCTI Research Foundation Liver Center

Coronado, California, United States

Kaiser Permanente

Los Angeles, California, United States

Lightspeed Medical

Los Angeles, California, United States

Anthony Mills MD, Inc.

Los Angeles, California, United States

Medical Associates Research Group

San Diego, California, United States

UCSD Antiviral Research Center

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

Quest Clinical Research

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

South Denver Gastroenterology

Englewood, Colorado, United States

Whitman Walker Clinic

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

University of Florida

Gainesville, Florida, United States

Borland-Groover Clinic

Jacksonville, Florida, United States

University of Miami, Center for Liver Diseases

Miami, Florida, United States

Advanced Research Institute

New Port Richey, Florida, United States

Orlando Immunology Center (ACH)

Orlando, Florida, United States

Internal Medicine Specialists

Orlando, Florida, United States

South Florida Center of Gastroenterology, P.A.

Wellington, Florida, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, United States

Graves-Gilbert Clinic

Bowling Green, Kentucky, United States

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, United States

Johns Hopkins University

Lutherville, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

The Research Institute

Springfield, Massachusetts, United States

Henry Ford Health System

Novi, Michigan, United States

Minnesota Gastroenterology, P.A.

Saint Paul, Minnesota, United States

Kansas City Gastroenterology and Hepatology

Kansas City, Missouri, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

ID Care

Hillsborough, New Jersey, United States

Binghamton Gastroenterology Associates

Binghamton, New York, United States

Weill Cornell Medical College

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Duke University

Durham, North Carolina, United States

Digestive Health Specialists, PA

Winston-Salem, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University Gastroenterology

Providence, Rhode Island, United States

Gastro One

Germantown, Tennessee, United States

Nashville Gastrointestinal Specialists, Inc

Nashville, Tennessee, United States

Southwest Infectious Disease Clinical Research, Inc.

Dallas, Texas, United States

Therapeutic Concepts, PA

Houston, Texas, United States

Alamo Medical Research

San Antonio, Texas, United States

Metropolitan Research

Fairfax, Virginia, United States

Inova Fairfax Hospital Center for Liver Diseases

Falls Church, Virginia, United States

Liver Institute of Virginia, Bon Secours St.Mary's

Newport News, Virginia, United States

Digestive and Liver Disease Specialists

Norfolk, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

St. Vincent's Hospital

Melbourne, , Australia

Monash Medical Centre

Melbourne, , Australia

University of Calgary

Calgary, Alberta, Canada

Gordon & Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

(G.I.R.I.) Gastrointestinal Research Institute

Vancouver, British Columbia, Canada

Toronto Liver Centre

Toronto, Ontario, Canada

CHUM - The Research Centre

Montreal, Quebec, Canada

Auckland Clinical Studies Limited

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Fundacion De Investigacion De Diego

San Juan, Puerto Rico, Puerto Rico

Clinical Research Puerto Rico Inc

San Juan, , Puerto Rico

Countries

United States; Australia; Canada; New Zealand; Puerto Rico

References

Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.

Reference Type: DERIVED

PMID: 25040192 (View on PubMed)

Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR; POSITRON Study; FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23.

Reference Type: DERIVED

PMID: 23607593 (View on PubMed)

Other Identifiers

GS-US-334-0107

Identifier Type: -

Identifier Source: org_study_id