Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
NCT ID: NCT02201953
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
558 participants
INTERVENTIONAL
2014-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF/VEL 12 Weeks
SOF/VEL FDC for 12 weeks
SOF/VEL
400/100 mg FDC tablet administered orally once daily
SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
SOF
400 mg tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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SOF/VEL
400/100 mg FDC tablet administered orally once daily
SOF
400 mg tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 10\^4 IU/mL
* HCV genotype 3
* Chronic HCV infection (≥ 6 months)
* Females of childbearing potential must have a negative serum pregnancy test
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion Criteria
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at Screening
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
* 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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John McNally, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
New York, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Darlinghurst, New South Wales, Australia
Brisbane, Queensland, Australia
Clayton, Victoria, Australia
Fitzroy, Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Fremantle, Western Australia, Australia
Perth, Western Australia, Australia
Camperdown, , Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Toronto, , Canada
Clermont-Ferrand, , France
Clichy, , France
Créteil, , France
Lille, , France
Limoges, , France
Lyon, , France
Marseille, , France
Paris, , France
Pessac, , France
Toulouse, , France
Villejuif, , France
Frankfurt am Main, Hessin, Germany
Cologne, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Hufelandstr, North Rhine-Westphalia, Germany
Berlin, , Germany
Berlin, , Germany
Hamburg, , Germany
Hanover, , Germany
München, , Germany
San Giovanni Rotondo, Foggia, Italy
Florence, , Italy
Auckland, , New Zealand
Christchurch, , New Zealand
San Juan, , Puerto Rico
Plymouth, Devon, United Kingdom
Portsmouth, Hampshire, United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Countries
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References
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Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.
Mangia, A., Roberts, SK., Pianko, S., Thompson, A at al. Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 24 Weeks in Genotype 3 HCV Infected Patients: The Randomized Controlled Phase 3 ASTRAL-3 Study. Hepatology 2015; 62: 1 (SUPPL) 338A.
Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.
Jacobson IM, Bourgeois S, Mathurin P, Thuluvath P, Ryder SD, Gerken G, Hernandez C, Vanstraelen K, Scherbakovsky S, Osinusi A, Tedesco D, Foster GR. The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis. J Viral Hepat. 2023 May;30(5):448-454. doi: 10.1111/jvh.13814. Epub 2023 Mar 2.
Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.
Other Identifiers
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2014-001682-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-342-1140
Identifier Type: -
Identifier Source: org_study_id
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