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Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT01909804
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : September 16, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SOF+VEL 25 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: SOF+VEL 25mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816

Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 100 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816

Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 25 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 100 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816

Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 25 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816

Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 100 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
 Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816

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


Outcome Measures
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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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any 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 SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. 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.


Eligibility Criteria
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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.


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

Inclusion Criteria:

  • Body mass index (BMI) ≥ 18 kg/m^2
  • HCV RNA ≥ 10000 IU/mL at screening
  • Prior treatment failure to a regimen including interferon with or without RBV
  • HCV genotype 1 or 3
  • Chronic HCV infection
  • Cirrhosis determination
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Current or prior history of clinically significant illness other than HCV
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to HCV specific direct acting antiviral agent
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of non-HCV etiology
  • Hepatitis B
  • Active drug abuse
  • Use of any prohibited concomitant medications
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01909804


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: John McNally Gilead Sciences
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston MA United States.

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01909804    
Other Study ID Numbers: GS-US-342-0109
First Posted: July 29, 2013    Key Record Dates
Results First Posted: September 16, 2016
Last Update Posted: November 15, 2018
Last Verified: July 2016
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 http://www.gilead.com/research/disclosure-and-transparency.
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: http://www.gilead.com/research/disclosure-and-transparency
Keywords provided by Gilead Sciences:
Hepatitis
Genotype 1
Genotype 3
Treatment experienced
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action