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

PHASE3CompletedINTERVENTIONAL
Enrollment

328

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

April 30, 2013

Conditions
Chronic Hepatitis C
Interventions
DRUG

Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

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)

DRUG

PEG

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Trial Locations (56)

10021

Weill Cornell Medical College, New York

10029

Mount Sinai School of Medicine, New York

13903

Binghamton Gastroenterology Associates, Binghamton

19104

Hospital of the University of Pennsylvania, Philadelphia

20009

Whitman Walker Clinic, Washington D.C.

20036

Capital Medical Associates, Washington D.C.

21093

Johns Hopkins University, Lutherville

22031

Metropolitan Research, Fairfax

22042

Inova Fairfax Hospital Center for Liver Diseases, Falls Church

23226

Bon Secours St. Mary's Hospital of Richmond, Inc., Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

27103

Digestive Health Specialists, PA, Winston-Salem

27710

Duke University Medical Center, Durham

28801

Asheville Gastroenterology Associates, P.A., Asheville

30033

Infectious Disease Specialist of Atlanta, Decatur

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30309

Digestive Healthcare of Georgia, Atlanta

32256

Borland-Groover Clinic Baptist, Jacksonville

32806

Internal Medicine Specialists, Orlando

33136

University of Miami Center for Liver Diseases, Miami

33414

South Florida Center of Gastroenterology, P.A., Wellington

34653

Advanced Research Institute, New Port Richey

37211

Nashville Gastrointestinal Specialists, Inc, Nashville

38138

Gastro One, Germantown

42101

Graves-Gilbert Clinic, Bowling Green

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48377

Henry Ford Health System, Novi

55114

Minnesota Gastroenterology, P.A., Saint Paul

64131

Kansas City Gastroenterology and Hepatology, Kansas City

70809

Gastroenterology Associates, LLC, Baton Rouge

75219

Southwest Infectious Disease Clinical Research, Inc., Dallas

77030

Research Specialists of Texas, Houston

78215

Alamo Medical Research, San Antonio

80045

University of Colorado, Aurora

80113

South Denver Gastroenterology, PC, Englewood

87505

Southwest C.A.R.E. Center, Santa Fe

90027

Kaiser Permanente, Los Angeles

90036

Peter J. Ruane, MD, Inc., Los Angeles

90069

Anthony Mills MD, Inc., Los Angeles

92103

University of California San Diego, San Diego

92118

SCTI Research Foundation, Coronado

92123

Medical Associates Research Group, Inc., San Diego

92154

Kaiser Permanente, San Diego

94115

Quest Clinical Research, San Francisco

98101

Virginia Mason Medical Center, Seattle

35294-2170

University of Alabama Birmingham, Birmingham

32610-0277

University of Florida, Gainesville

32803-1851

Orlando Immunology Center (ACH), Orlando

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01105

The Research Institute, Springfield

08009

Comprehensive Clinical Research, Berlin

08844

ID Care, Hillsborough

02905

University Gastroenterology, Providence

02906

The Miriam Hospital, Providence

00927

Fundacion De Investigacion De Diego, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY