Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2012
End Date:December 2014

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An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)
in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults
with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study
and have not achieved sustained virologic response (SVR).


Inclusion Criteria:

- Infection with HCV

- Must have participated in a prior Gilead HCV study

- Use of highly effective contraception methods if female of childbearing potential or
sexually active male

- Eligible patients include those in the following

- received placebo or Peg-IFN+RBV in a control arm

- previously participated in a Gilead-sponsored HCV study and did not attain
sustained virologic response 24 weeks after discontinuation of therapy (SVR24)
on a regimen containing:

- Sofosbuvir+RBV

- Peg-IFN and/or RBV in combination with one or more Gilead investigational
direct-acting agents

Exclusion Criteria:

- Pregnant or nursing female or male with pregnant female partner

- Current or prior history of clinical hepatic decompensation

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

- Chronic use of systemically administered immunosuppressive agents

- Active drug abuse

- Use of any prohibited concomitant medications
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Bradenton, FL
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Orlando, Florida 32806
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
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Arlington, Texas 76012
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Asheville, North Carolina 28803
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Atlanta, Georgia 30342
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Atlanta, Georgia 30309
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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Bakersfield, California 93301
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Baltimore, Maryland 21229
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Binghamton, New York 13903
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Chapel Hill, North Carolina 27599
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Colton, California 92324
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Concord, New South Wales
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Detroit, Michigan 48202
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Englewood, Colorado 80113
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Fairfax, Virginia 22031
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Germantown, Tennessee 38138
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La Mesa, California 91942
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1101 East 33rd Street
Lutherville, Maryland 21093
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Marietta, GA
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Nashville, Tennessee 37205
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New York, New York 10021
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Newport News, Virginia 23602
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Novi, Michigan 48377
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Oceanside, California 92056
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Providence, Rhode Island 02905
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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San Antonio, Texas 78215
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San Francisco, California 94115
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Springfield, Massachusetts 01105
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St. Paul, Minnesota 55114
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Statesville, North Carolina 28677
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Township, New Jersey 08234
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Trinity, Florida 34655
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Vineland, New Jersey 08360
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Washington, District of Columbia 20009
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Winston Salem, North Carolina 27103
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