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Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor (POLARIS-4)

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ClinicalTrials.gov Identifier: NCT02639247
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : November 6, 2017
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL/VOX Drug: SOF/VEL Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Actual Study Start Date : December 23, 2015
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : January 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Arm Intervention/treatment
Experimental: SOF/VEL/VOX
SOF/VEL/VOX for 12 weeks
400/100/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Vosevi®
  • GS-7977/GS-5816/GS-9857

Experimental: SOF/VEL
SOF/VEL for 12 weeks
400/100 mg FDC tablet administered orally once daily without regard to food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
  3. Change From Baseline in HCV RNA [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  4. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
      • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
      • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    • Virologic relapse:

      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • 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 not including a NS5A Inhibitor for HCV
  • Use of protocol specified methods of contraception

Key Exclusion Criteria:

  • 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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639247

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Sponsors and Collaborators
Gilead Sciences
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Study Director: Gilead Study Director Gilead Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02639247    
Other Study ID Numbers: GS-US-367-1170
2015-003167-10 ( EudraCT Number )
First Posted: December 24, 2015    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: March 5, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/about/ethics-and-code-of-conduct/policies

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
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Communicable Diseases
Hepatitis C
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents