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
ASTRAL-3
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
2 other identifiers
interventional
558
9 countries
76
Brief Summary
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2014
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
October 26, 2016
CompletedNovember 16, 2018
September 1, 2016
1.2 years
July 24, 2014
September 1, 2016
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes (4)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (2)
SOF/VEL 12 Weeks
EXPERIMENTALSOF/VEL FDC for 12 weeks
SOF+RBV 24 Weeks
EXPERIMENTALSOF+RBV for 24 weeks
Interventions
400/100 mg FDC tablet administered orally once daily
400 mg tablet administered orally once daily
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)
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- 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
You may not qualify if:
- Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (76)
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Los Angeles, California, 90048, United States
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Sacramento, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Wellington, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lutherville, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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New York, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Germantown, Tennessee, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Darlinghurst, New South Wales, 2010, Australia
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Brisbane, Queensland, 4064, Australia
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Clayton, Victoria, 3168, Australia
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Fitzroy, Melbourne, Victoria, 3065, Australia
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Melbourne, Victoria, 3004, Australia
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Fremantle, Western Australia, 6010, Australia
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Perth, Western Australia, 6000, Australia
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Camperdown, Australia
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 2C7, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Toronto, M5T 2S8, Canada
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Clermont-Ferrand, 63000, France
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Clichy, 92110, France
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Créteil, 94000, France
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Lille, 59037, France
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Limoges, 87042, France
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Lyon, 69004, France
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Marseille, 13008, France
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Paris, 75014, France
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Pessac, France
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Toulouse, 31059, France
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Villejuif, 94804, France
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Frankfurt am Main, Hessin, 60590, Germany
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Cologne, North Rhine-Westphalia, 50932, Germany
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Düsseldorf, North Rhine-Westphalia, 40237, Germany
Unknown Facility
Hufelandstr, North Rhine-Westphalia, 45122, Germany
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Berlin, 12157, Germany
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Berlin, D-10969, Germany
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Hamburg, Germany
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Hanover, 30625, Germany
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München, 81377, Germany
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San Giovanni Rotondo, Foggia, 71013, Italy
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Florence, 50012, Italy
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Auckland, New Zealand
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Christchurch, 8011, New Zealand
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San Juan, Puerto Rico
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Plymouth, Devon, PL6 8DH, United Kingdom
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Portsmouth, Hampshire, PO6 3LY, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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London, E1 4AT, United Kingdom
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London, NW3 2PF, United Kingdom
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London, SE5 9RS, United Kingdom
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London, SW170QT, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
Unknown Facility
Oxford, OX3 9DU, United Kingdom
Related Publications (5)
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.
RESULTMangia, 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.
RESULTFoster 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.
PMID: 26575258RESULTJacobson 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.
PMID: 36740893DERIVEDYounossi 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.
PMID: 27847279DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
John McNally, PhD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2014
First Posted
July 28, 2014
Study Start
July 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
November 16, 2018
Results First Posted
October 26, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.