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

May 21, 2012
May 9, 2014
June 2012
February 2013   (final data collection date for primary outcome measure)
  • 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.
  • Efficacy 12 weeks post dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of patients with a sustained virologic response (SVR) 12 weeks after the end of treatment
  • The safety and tolerability of GS-7977+RBV when given for 12 or 16 weeks [ Time Frame: 12 or 16 weeks ] [ Designated as safety issue: Yes ]
    The safety and tolerability of GS-7977+RBV when given for 12 or 16 weeks as measured by review of the accumulated safety data
Complete list of historical versions of study NCT01604850 on ClinicalTrials.gov Archive Site
  • 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).

  • Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 weeks and 24 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
  • Amount of circulating HCV RNA [ Time Frame: 12 weeks post dosing ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation
  • Characterization of viral resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation
Not Provided
Not Provided
 
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C
  • 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+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.
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: Placebo to match SOF
    • Drug: Placebo to match RBV
  • Experimental: SOF+RBV
    Participants were randomized to receive SOF+RBV for 16 weeks.
    Interventions:
    • Drug: SOF
    • Drug: RBV

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
May 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   New Zealand,   Puerto Rico
 
NCT01604850
GS-US-334-0108
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP