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

Chronic Hepatitis C Clinical Trial

— NEUTRINO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641640
• Other study ID #: GS-US-334-0110
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2012
• Last updated: April 8, 2014
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
• 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)
• PEG
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection

Locations

Country	Name	City	State
Puerto Rico	Fundacion De Investigacion De Diego	San Juan
United States	Asheville Gastroenterology Associates, P.A.	Asheville	North Carolina
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Binghamton Gastroenterology Associates	Binghamton	New York
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	SCTI Research Foundation	Coronado	California
United States	Southwest Infectious Disease Clinical Research, Inc.	Dallas	Texas
United States	Infectious Disease Specialist of Atlanta	Decatur	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	South Denver Gastroenterology, PC	Englewood	Colorado
United States	Metropolitan Research	Fairfax	Virginia
United States	Inova Fairfax Hospital Center for Liver Diseases	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	ID Care	Hillsborough	New Jersey
United States	Research Specialists of Texas	Houston	Texas
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	Borland-Groover Clinic Baptist	Jacksonville	Florida
United States	Kansas City Gastroenterology and Hepatology	Kansas City	Missouri
United States	Anthony Mills MD, Inc.	Los Angeles	California
United States	Kaiser Permanente	Los Angeles	California
United States	Peter J. Ruane, MD, Inc.	Los Angeles	California
United States	Johns Hopkins University	Lutherville	Maryland
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	University of Miami Center for Liver Diseases	Miami	Florida
United States	Nashville Gastrointestinal Specialists, Inc	Nashville	Tennessee
United States	Advanced Research Institute	New Port Richey	Florida
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Henry Ford Health System	Novi	Michigan
United States	Internal Medicine Specialists	Orlando	Florida
United States	Orlando Immunology Center (ACH)	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Miriam Hospital	Providence	Rhode Island
United States	University Gastroenterology	Providence	Rhode Island
United States	Bon Secours St. Mary's Hospital of Richmond, Inc.	Richmond	Virginia
United States	Alamo Medical Research	San Antonio	Texas
United States	Kaiser Permanente	San Diego	California
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	University of California San Diego	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Southwest C.A.R.E. Center	Santa Fe	New Mexico
United States	Virginia Mason Medical Center	Seattle	Washington
United States	The Research Institute	Springfield	Massachusetts
United States	Minnesota Gastroenterology, P.A.	St. Paul	Minnesota
United States	Capital Medical Associates	Washington	District of Columbia
United States	Whitman Walker Clinic	Washington	District of Columbia
United States	South Florida Center of Gastroenterology, P.A.	Wellington	Florida
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sustained Virologic Response (SVR)12	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.	Posttreatment Week 12	No
Primary	Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug	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.	Baseline to Week 12	No
Secondary	Percentage of Participants Achieving SVR4	SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy	Posttreatment Week 4	No
Secondary	Percentage of Participants Achieving SVR24	SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy	Posttreatment Week 24	No
Secondary	Percentage of Participants With Viral Breakthrough	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	No
Secondary	Percentage of Participants With Viral Relapse	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	No