Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
POLARIS-2
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection
2 other identifiers
interventional
943
8 countries
93
Brief Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic 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 Nov 2015
Shorter than P25 for phase_3
93 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
First Submitted
Initial submission to the registry
November 16, 2015
CompletedStudy Start
First participant enrolled
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
January 11, 2017
CompletedResults Posted
Study results publicly available
November 8, 2017
CompletedMarch 5, 2019
October 1, 2017
11 months
November 16, 2015
October 10, 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)
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 Discontinue Study Drug Due to an Adverse Event
Up to 12 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 On Treatment
Weeks 1, 2, 4, 8, and 12
Change From Baseline in HCV RNA
Baseline; Weeks 1, 2, 4, 8, and 12
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (2)
SOF/VEL/VOX
EXPERIMENTALSOF/VEL/VOX tablet for 8 weeks
SOF/VEL 12 weeks
ACTIVE COMPARATORSOF/VEL tablet for 12 weeks
Interventions
400/100/100 mg tablet administered orally once daily with food
400/100 mg tablet administered orally once daily with or without 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)
- HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
- 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 parameters outside the acceptable range 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 (93)
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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Bastrop, Louisiana, 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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Manhasset, New York, 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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Fayetteville, 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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Live Oak, 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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Darlinghurst, New South Wales, Australia
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Herston, Queensland, Australia
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Fitzroy, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, 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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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Bobigny, France
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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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Orléans, 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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Oxford, United Kingdom
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Portsmouth, United Kingdom
Related Publications (2)
Jacobson IM, Asselah T, Nahass R, Bhandari BR, Tran A, Hyland RH, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study [Abstract LB-12]. Hepatology AASLD Abstracts 2016;64 (6 (suppl)):1126A.
RESULTJacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.
PMID: 28390869RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- 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
- NONE
- 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 16, 2015
Primary Completion
October 10, 2016
Study Completion
January 11, 2017
Last Updated
March 5, 2019
Results First Posted
November 8, 2017
Record last verified: 2017-10
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.