Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT ID: NCT02607735
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
416 participants
INTERVENTIONAL
2015-11-11
2017-06-21
Brief Summary
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Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SOF/VEL/VOX (Primary Study)
SOF/VEL/VOX for 12 weeks
SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Placebo (Primary Study)
Placebo to match SOF/VEL/VOX for 12 weeks
Placebo
Tablet administered orally once daily with food
SOF/VEL/VOX (Deferred Treatment Substudy)
SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Interventions
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SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Placebo
Tablet administered orally once daily with food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months)
* Treatment experienced with a direct acting antiviral medication for HCV
* Use of protocol specified methods of contraception
Exclusion Criteria
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Long Beach, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Pasadena, California, United States
Rialto, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Catonsville, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Hillsborough, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Camperdown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Herston, Queensland, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Brampton, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Clermont-Ferrand, , France
Clichy, , France
Créteil, , France
Grenoble, , France
Lille, , France
Limoges, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nice, , France
Paris, , France
Pessac, , France
Rennes, , France
Rouen, , France
Strasbourg, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Christchurch, , New Zealand
Grafton, , New Zealand
San Juan, , Puerto Rico
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Portsmouth, , United Kingdom
Countries
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References
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Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A.
Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16.
Bourliere M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31.
Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.
Other Identifiers
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2015-003455-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-367-1171
Identifier Type: -
Identifier Source: org_study_id
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