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Trial record 10 of 18 for:    gs-9857

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)

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ClinicalTrials.gov Identifier: NCT02607735
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : December 13, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : October 10, 2016
Actual Study Completion Date : June 21, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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

Experimental: Placebo (Primary Study)
Placebo to match SOF/VEL/VOX for 12 weeks
Drug: Placebo
Tablet administered orally once daily with food

Experimental: SOF/VEL/VOX (Deferred Treatment Substudy)
SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
Drug: SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Other Names:
  • Vosevi®
  • GS-7977/GS-5816/GS-9857




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) [ 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 Discontinued Study Drug Due to an Adverse Event (Primary Study) [ Time Frame: Up to 12 weeks ]

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

  2. Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study) [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
  3. Change From Baseline in HCV RNA (Primary Study) [ Time Frame: Baseline; Weeks 1, 2, 4, 8 and 12 ]
  4. Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study) [ Time Frame: Posttreatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

  5. Percentage of Participants With Virologic Failure (Primary Study) [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure is 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.

  6. Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) [ Time Frame: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy) ]
    SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.

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

    Virologic failure is 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.



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
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)
  • Treatment experienced with a direct acting antiviral medication 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): NCT02607735


  Show 86 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Publications of Results:
Other Publications:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607735     History of Changes
Other Study ID Numbers: GS-US-367-1171
2015-003455-21 ( EudraCT Number )
First Posted: November 18, 2015    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: August 21, 2018
Last Verified: July 2018

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
Sofosbuvir-velpatasvir drug combination
Anti-Infective Agents