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

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ClinicalTrials.gov Identifier: NCT01604850
Recruitment Status : Completed
First Posted : May 24, 2012
Results First Posted : May 1, 2014
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: SOF Drug: RBV Drug: Placebo to match SOF Drug: Placebo to match RBV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving SVR12 [ Time Frame: Posttreatment Week 12 ]

    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).


  2. Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 16 ]
    Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ]

    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).


  2. Percentage of Participants Achieving SVR24 [ Time Frame: Posttreatment Week 24 ]

    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).


  3. Percentage of Participants With Viral Breakthrough [ Time Frame: Up to 16 weeks ]

    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).


  4. Percentage of Participants With Viral Relapse [ Time Frame: End of treatment to posttreatment Week 24 ]

    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).



Eligibility Criteria
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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

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
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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): NCT01604850


Locations
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Sponsors and Collaborators
Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01604850    
Other Study ID Numbers: GS-US-334-0108
First Posted: May 24, 2012    Key Record Dates
Results First Posted: May 1, 2014
Last Update Posted: May 28, 2014
Last Verified: May 2014
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:
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Hepatitis C
Hepatitis C, Chronic
Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Hepatitis, Viral, Human
Virus Diseases
 Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes
Sofosbuvir
Antiviral Agents
Anti-Infective Agents