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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

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ClinicalTrials.gov Identifier: NCT02536313
Recruitment Status : Completed
First Posted : August 31, 2015
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL/VOX Drug: RBV Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
Actual Study Start Date : July 29, 2015
Actual Primary Completion Date : March 28, 2016
Actual Study Completion Date : June 28, 2016

Resource links provided by the National Library of Medicine


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

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

Drug: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX 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 SVR 24 are 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. HCV RNA Change From Baseline/Day 1 Through Week 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  4. Percentage of Participants With Virologic Failure [ 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.



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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:

  • Individuals with chronic HCV genotype 1 infection
  • Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
  • Absence of cirrhosis or presence of compensated cirrhosis
  • Screening laboratory values within defined thresholds
  • Must use specific contraceptive methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

  • Co-infection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Pregnant or a nursing female

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): NCT02536313


Locations
United States, Texas
The Texas Liver Institute
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Publications:
Lawitz E, Poordad F, Wells J, Hyland RH, Yang Y, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Landaverde C, Gutierrez J. High Efficacy of Sofosbuvir/Velpatasvir/GS-9857 With or Without Ribavirin for 12 Weeks in Direct Acting Antiviral-Experienced Patients With Genotype 1 HCV Infection [Presentation PS021]. J Hepatol 2016; 64: S146.

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02536313     History of Changes
Other Study ID Numbers: GS-US-367-1871
First Posted: August 31, 2015    Key Record Dates
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis C
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Antiviral Agents
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents