Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection (NEUTRINO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01641640
First received: July 9, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).


Condition Intervention Phase
Chronic Hepatitis C
Drug: Sofosbuvir
Drug: RBV
Drug: PEG
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants Achieving Sustained Virologic Response (SVR)12 [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.

  • Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.


Secondary Outcome Measures:
  • Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ] [ Designated as safety issue: No ]
    SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy

  • Percentage of Participants Achieving SVR24 [ Time Frame: Posttreatment Week 24 ] [ Designated as safety issue: No ]
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy

  • Percentage of Participants With Viral Breakthrough [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Viral Relapse [ Time Frame: End of treatment to post-treatment Week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 328
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+PEG+RBV Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: PEGASYS®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection with HCV genotype 1, 4, 5, or 6
  • Cirrhosis determination
  • Subject met the following classifications:

    • Treatment-naive
    • Screening laboratory values within defined thresholds
    • Not treated with any investigational drug or device within 30 days of screening
  • 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 have interfered with subject treatment, assessment, or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641640

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294-2170
United States, California
SCTI Research Foundation
Coronado, California, United States, 92118
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Anthony Mills MD, Inc.
Los Angeles, California, United States, 90069
Kaiser Permanente
Los Angeles, California, United States, 90027
University of California San Diego
San Diego, California, United States, 92103
Kaiser Permanente
San Diego, California, United States, 92154
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
South Denver Gastroenterology, PC
Englewood, Colorado, United States, 80113
United States, District of Columbia
Capital Medical Associates
Washington, District of Columbia, United States, 20036
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0277
Borland-Groover Clinic Baptist
Jacksonville, Florida, United States, 32256
University of Miami Center for Liver Diseases
Miami, Florida, United States, 33136
Advanced Research Institute
New Port Richey, Florida, United States, 34653
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Orlando Immunology Center (ACH)
Orlando, Florida, United States, 32803-1851
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, United States, 33414
United States, Georgia
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
Infectious Disease Specialist of Atlanta
Decatur, Georgia, United States, 30033
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
United States, Indiana
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
The Research Institute
Springfield, Massachusetts, United States, 01105
United States, Michigan
Henry Ford Health System
Novi, Michigan, United States, 48377
United States, Minnesota
Minnesota Gastroenterology, P.A.
St. Paul, Minnesota, United States, 55114
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
ID Care
Hillsborough, New Jersey, United States, 08844
United States, New Mexico
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Binghamton Gastroenterology Associates
Binghamton, New York, United States, 13903
Mount Sinai School of Medicine
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States, 28801
Duke University Medical Center
Durham, North Carolina, United States, 27710
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States, 37211
United States, Texas
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States, 75219
Research Specialists of Texas
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, United States, 22042
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, United States, 23226
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Puerto Rico
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01641640     History of Changes
Other Study ID Numbers: GS-US-334-0110
Study First Received: July 9, 2012
Results First Received: February 25, 2014
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 1 (GT-1)
HCV genotype 4 (GT-4)
HCV genotype 5 (GT-5)
HCV genotype 6 (GT-6)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Treatment-Naïve
GS-7977
Ribavirin
RBV
Peginterferon Alfa 2a
PEG

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014