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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02607800
First Posted: November 18, 2015
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
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.

Condition Intervention Phase
Hepatitis C Drug: SOF/VEL/VOX Drug: SOF/VEL Phase 3

Study Type: Interventional
Study Design: 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 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.

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

Secondary Outcome Measures:
  • 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 SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

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

    Virologic failure was defined as:

    • 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


Enrollment: 943
Actual Study Start Date: November 16, 2015
Study Completion Date: January 11, 2017
Primary Completion Date: October 10, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF/VEL/VOX
SOF/VEL/VOX tablet for 8 weeks
Drug: SOF/VEL/VOX
400/100/100 mg tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816/GS-9857
  • Vosevi®
Active Comparator: SOF/VEL 12 weeks
SOF/VEL tablet for 12 weeks
Drug: SOF/VEL
400/100 mg tablet administered orally once daily with or without food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Key Inclusion Criteria:

  • 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

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 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)

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

  Contacts and Locations
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): NCT02607800


  Show 93 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Publications:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607800     History of Changes
Other Study ID Numbers: GS-US-367-1172
2015-003460-36 ( EudraCT Number )
First Submitted: November 16, 2015
First Posted: November 18, 2015
Results First Submitted: October 10, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Chronic Hepatitis C Infection

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Sofosbuvir
Anti-Infective Agents