Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
POLARIS-1
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
2 other identifiers
interventional
416
8 countries
86
Brief Summary
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy. Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2015
86 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
November 11, 2015
CompletedFirst Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2017
CompletedResults Posted
Study results publicly available
December 13, 2017
CompletedMarch 5, 2019
July 1, 2018
11 months
November 16, 2015
October 4, 2017
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
Up to 12 weeks
Secondary Outcomes (9)
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Weeks 1, 2, 4, 8 and 12
Change From Baseline in HCV RNA (Primary Study)
Baseline; Weeks 1, 2, 4, 8 and 12
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
Posttreatment Week 24
Percentage of Participants With Virologic Failure (Primary Study)
Up to Posttreatment Week 24
- +4 more secondary outcomes
Study Arms (3)
SOF/VEL/VOX (Primary Study)
EXPERIMENTALSOF/VEL/VOX for 12 weeks
Placebo (Primary Study)
EXPERIMENTALPlacebo to match SOF/VEL/VOX for 12 weeks
SOF/VEL/VOX (Deferred Treatment Substudy)
EXPERIMENTALSOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
Interventions
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- 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
You may not qualify if:
- Current or prior history of clinically significant illness that may interfere with participation in the study
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (86)
Unknown Facility
Long Beach, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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Pasadena, California, United States
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Rialto, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Englewood, Colorado, United States
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Washington D.C., District of Columbia, United States
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Gainesville, 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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Atlanta, Georgia, 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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Baltimore, Maryland, United States
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Catonsville, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Hillsborough, New Jersey, 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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Asheville, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Falls Church, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Camperdown, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Herston, Queensland, Australia
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Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Melbourne, Victoria, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Clermont-Ferrand, France
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Clichy, France
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Créteil, France
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Grenoble, France
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Lille, France
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Limoges, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Nice, France
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Paris, France
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Pessac, France
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Rennes, France
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Rouen, France
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Strasbourg, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Villejuif, France
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Berlin, Germany
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Bonn, Germany
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Cologne, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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Hanover, Germany
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Christchurch, New Zealand
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Grafton, New Zealand
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San Juan, Puerto Rico
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London, United Kingdom
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Manchester, United Kingdom
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Nottingham, United Kingdom
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Portsmouth, United Kingdom
Related Publications (4)
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.
BACKGROUNDYounossi 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.
PMID: 29155352BACKGROUNDBourliere 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.
PMID: 29859740BACKGROUNDBourliere 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.
PMID: 28564569RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2015
First Posted
November 18, 2015
Study Start
November 11, 2015
Primary Completion
October 10, 2016
Study Completion
June 21, 2017
Last Updated
March 5, 2019
Results First Posted
December 13, 2017
Record last verified: 2018-07
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 https://www.gilead.com/about/ethics-and-code-of-conduct/policies.