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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)

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
Results First Received: March 31, 2014  
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
Condition: Chronic Hepatitis C
Interventions: Drug: SOF
Drug: RBV
Drug: Placebo to match SOF
Drug: Placebo to match RBV

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in a total of 57 study sites in the United States, Canada, and New Zealand. The first participant was screened on 04 June 2012. The last participant observation was on 08 May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
277 participants were screened and 202 were randomized. Of those participants randomized, 201 received at least one dose of study drug, and comprise the Safety Analysis Set; 195 of those participants with genotypes 2 or 3 HCV infection were treated and comprise the Full Analysis Set.

Reporting Groups
  Description
SOF+RBV+Placebo

Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets.

SOF+RBV

Participants were randomized to receive sofosbuvir+RBV for 16 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets.


Participant Flow:   Overall Study
    SOF+RBV+Placebo   SOF+RBV
STARTED   103   99 
Enrolled and Treated   103   98 
COMPLETED   51   69 
NOT COMPLETED   52   30 
Enrolled but never treated                0                1 
Efficacy Failure                50                29 
Lost to Follow-up                1                0 
Subject withdrew consent                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.

Reporting Groups
  Description
SOF+RBV+Placebo

Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets.

SOF+RBV

Participants were randomized to receive sofosbuvir+RBV for 16 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets.

Total Total of all reporting groups

Baseline Measures
   SOF+RBV+Placebo   SOF+RBV   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   98   201 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (7.7)   54  (7.8)   54  (7.8) 
Gender 
[Units: Participants]
     
Female   30   31   61 
Male   73   67   140 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black or African American   5   1   6 
White   88   86   174 
Asian   7   5   12 
American Indian/ Alaska Native/ First Nations   1   3   4 
Hawaiian or Pacific Islander   0   1   1 
Other   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   74   76   150 
Canada   26   17   43 
New Zealand   3   5   8 
Hepatitis C Virus (HCV) genotype 
[Units: Participants]
     
Genotype 1   3   3   6 
Genotype 2   36   32   68 
Genotype 3   64   63   127 
HCV RNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 6.5  (0.67)   6.5  (0.63)   6.5  (0.65) 
HCV RNA Category 
[Units: Participants]
     
< 6 log10 IU/mL   26   29   55 
≥ 6 log10 IU/mL   77   69   146 
IL28 Genotype [1] 
[Units: Participants]
     
CC   31   30   61 
CT   53   56   109 
TT   19   12   31 
[1] CC, CT, and TT alleles are different forms of the IL28b gene.
Cirrhosis (Y/N) 
[Units: Participants]
     
No   66   66   132 
Yes   36   32   68 
Missing   1   0   1 
Response to Prior HCV Treatment 
[Units: Participants]
     
Nonresponse   25   25   50 
Relapse/Breakthrough   78   73   151 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Adverse Events Leading to Permanent Discontinuation of Study Drug   [ Time Frame: Baseline to Week 16 ]

3.  Secondary:   Percentage of Participants Achieving SVR4   [ Time Frame: Posttreatment Week 4 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


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