Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:June 2013
End Date:August 2014

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A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV)
infection.


Inclusion Criteria:

- Body mass index (BMI) ≥ 18 kg/m^2

- HCV RNA ≥ 10000 IU/mL at screening

- Prior treatment failure to a regimen including interferon with or without RBV

- HCV genotype 1 or 3

- Chronic HCV infection

- Cirrhosis determination

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

Exclusion Criteria:

- Current or prior history of clinically significant illness other than HCV

- Screening ECG with clinically significant abnormalities

- Prior exposure to HCV specific direct acting antiviral agent

- Pregnant or nursing female or male with pregnant female partner

- Chronic liver disease of non-HCV etiology

- Hepatitis B

- Active drug abuse

- Use of any prohibited concomitant medications
We found this trial at
41
sites
1284
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Santa Fe, NM
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320
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Annandale, VA
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Arlington, TX
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Asheville, NC
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Atlanta, GA
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Baltimore, MD
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Boston, MA
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9459
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Camperdown,
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274
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Chicago, IL
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910
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Dallas, TX
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Denver, CO
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163
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Detroit, MI
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354
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Durham, NC
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316
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Fairfax, VA
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Fayetteville, North Carolina 28304
408
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Fayetteville, NC
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711
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Gainesville, FL
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501
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Germantown, TN
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492
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Great Neck, NY
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442
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Hillsborough, NJ
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166
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Indianapolis, IN
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668
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Jacksonville, FL
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1975
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Long Beach, CA
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Los Angeles, CA
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425
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Marietta, GA
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993
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Miami, FL
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331
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Nashville, TN
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New York, NY
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407
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Newport News, VA
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Norfolk, VA
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792
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Orlando, FL
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Pasadena, CA
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Philadelphia, PA
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Pittsburgh, PA
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Portland, OR
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Providence, RI
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San Antonio, TX
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San Diego, CA
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2005
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Seattle, WA
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Tampa, FL
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933
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Wellington, FL
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306
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Winston-Salem, NC
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