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: September 9, 2013
Last verified: September 2013

May 21, 2012
September 9, 2013
June 2012
May 2013   (final data collection date for primary outcome measure)
  • 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 sofosbuvir+RBV when given for 12 or 16 weeks [ Time Frame: 12 or 16 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of sofosbuvir+RBV when given for 12 or 16 weeks as measured by review of the accumulated safety data
Same as current
Complete list of historical versions of study NCT01604850 on ClinicalTrials.gov Archive Site
  • 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 sofosbuvir during treatment and after treatment discontinuation
  • 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 is to assess whether sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks is safe and effective in patients with hepatitis C (HCV) genotype 2 or 3 (GT-2 or GT-3) as assessed by the rate of sustained viral 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: Sofosbuvir
    Sofosbuvir 400 mg tablet administered orally once daily
    Other Names:
    • GS-7977
    • PSI-7977
  • Drug: Ribavirin
    Ribavirin (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)
  • Experimental: Sofosbuvir+ribavirin for 12 weeks
    Interventions:
    • Drug: Sofosbuvir
    • Drug: Ribavirin
  • Experimental: Sofosbuvir+ribavirin for 16 weeks
    Interventions:
    • Drug: Sofosbuvir
    • Drug: Ribavirin
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23.

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

Inclusion Criteria:

  • Infection with HCV genotype 2 or 3
  • Cirrhosis determination
  • Subject meets the following classifications:

    • Prior treatment failure

  • Screening laboratory values within defined thresholds
  • Subject has 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 interfere 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
September 2013

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