Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01604850
First received: May 21, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).


Condition Intervention Phase
Chronic Hepatitis C
Drug: SOF
Drug: RBV
Drug: Placebo to match SOF
Drug: Placebo to match RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants Achieving SVR12 [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.

    For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).


  • Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.


Secondary Outcome Measures:
  • Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ] [ Designated as safety issue: No ]

    SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.

    For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).


  • Percentage of Participants Achieving SVR24 [ Time Frame: Posttreatment Week 24 ] [ Designated as safety issue: No ]

    SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.

    For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).


  • Percentage of Participants With Viral Breakthrough [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

    Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.

    For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).


  • Percentage of Participants With Viral Relapse [ Time Frame: End of treatment to posttreatment Week 24 ] [ Designated as safety issue: No ]

    Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

    For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).



Enrollment: 202
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF+RBV+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Drug: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Drug: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Experimental: SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection with HCV genotype 2 or 3
  • Had cirrhosis determination
  • Prior treatment failure
  • Screening laboratory values within defined thresholds
  • Subject had not been treated with any investigational drug or device within 30 days of the screening visit
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604850

  Show 67 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01604850     History of Changes
Other Study ID Numbers: GS-US-334-0108
Study First Received: May 21, 2012
Results First Received: March 31, 2014
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Treatment Experienced
GS-7977
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014