Clinical trial NCT01641640: Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: 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
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response (SVR)12
timeFrame: Posttreatment Week 12
measure: Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving SVR4
timeFrame: Posttreatment Week 4
measure: Percentage of Participants Achieving SVR24
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Viral Relapse
timeFrame: End of treatment to post-treatment Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Coronado
country: United States
facility: SCTI Research Foundation
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD, Inc.
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Washington
country: United States
facility: Whitman Walker Clinic
state: District of Columbia
city: Washington
country: United States
facility: Capital Medical Associates
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic Baptist
state: Florida
city: Miami
country: United States
facility: University of Miami Center for Liver Diseases
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center (ACH)
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology, P.A.
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialist of Atlanta
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: St. Paul
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest C.A.R.E. Center
state: New Mexico
city: Binghamton
country: United States
facility: Binghamton Gastroenterology Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists, Inc
state: Tennessee
city: Dallas
country: United States
facility: Southwest Infectious Disease Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital Center for Liver Diseases
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc.
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
Study officials:
References:
citation: Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
citation: Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F, Hunt S. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.
citation: 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.