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
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, 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 |
Enrollment | 202 |
Recruitment Details | 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 | 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. |
Arm/Group Title | SOF+RBV+Placebo | SOF+RBV |
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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. |
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. |
Period Title: Overall Study | ||
Started | 103 | 99 |
Enrolled and Treated | 103 | 98 |
Completed | 51 | 69 |
Not Completed | 52 | 30 |
Reason Not Completed | ||
Enrolled but never treated | 0 | 1 |
Efficacy Failure | 50 | 29 |
Lost to Follow-up | 1 | 0 |
Subject withdrew consent | 1 | 0 |
Arm/Group Title | SOF+RBV+Placebo | SOF+RBV | Total | |
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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. |
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 of all reporting groups | |
Overall Number of Baseline Participants | 103 | 98 | 201 | |
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Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 103 participants | 98 participants | 201 participants | |
54 (7.7) | 54 (7.8) | 54 (7.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 103 participants | 98 participants | 201 participants | |
Female |
30 29.1%
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31 31.6%
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61 30.3%
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Male |
73 70.9%
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67 68.4%
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140 69.7%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 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
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 participants |
United States | 74 | 76 | 150 | |
Canada | 26 | 17 | 43 | |
New Zealand | 3 | 5 | 8 | |
Hepatitis C Virus (HCV) genotype
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 participants |
Genotype 1 | 3 | 3 | 6 | |
Genotype 2 | 36 | 32 | 68 | |
Genotype 3 | 64 | 63 | 127 | |
HCV RNA
Mean (Standard Deviation) Unit of measure: Log10 IU/mL |
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Number Analyzed | 103 participants | 98 participants | 201 participants | |
6.5 (0.67) | 6.5 (0.63) | 6.5 (0.65) | ||
HCV RNA Category
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 participants |
< 6 log10 IU/mL | 26 | 29 | 55 | |
≥ 6 log10 IU/mL | 77 | 69 | 146 | |
IL28 Genotype
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 participants |
CC | 31 | 30 | 61 | |
CT | 53 | 56 | 109 | |
TT | 19 | 12 | 31 | |
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
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Cirrhosis (Y/N)
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 participants |
No | 66 | 66 | 132 | |
Yes | 36 | 32 | 68 | |
Missing | 1 | 0 | 1 | |
Response to Prior HCV Treatment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 98 participants | 201 participants |
Nonresponse | 25 | 25 | 50 | |
Relapse/Breakthrough | 78 | 73 | 151 |
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
- The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
- The study has been completed at all study sites for at least 2 years
Name/Title: | Clinical Trial Disclosures |
Organization: | Gilead Sciences, Inc. |
EMail: | ClinicalTrialDisclosures@gilead.com |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01604850 |
Other Study ID Numbers: |
GS-US-334-0108 |
First Submitted: | May 21, 2012 |
First Posted: | May 24, 2012 |
Results First Submitted: | March 31, 2014 |
Results First Posted: | May 1, 2014 |
Last Update Posted: | May 28, 2014 |