Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01625338
First received: June 7, 2012
Last updated: October 9, 2015
Last verified: October 2015
Results First Received: October 9, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: SOF
Drug: RBV
Drug: Peg-IFN

  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
Participants were enrolled at a total of 152 study sites from their prior Gilead study in North America, Europe, Australia, and New Zealand. The first participant was screened on 22 June 2012. The last study visit occurred on 22 December 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
585 participants were screened.

Reporting Groups
  Description
SOF+RBV 12 Weeks Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
SOF+RBV 24 Weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
SOF+RBV+Peg-IFN 12 Weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants

Participant Flow:   Overall Study
    SOF+RBV 12 Weeks     SOF+RBV 24 Weeks     SOF+RBV+Peg-IFN 12 Weeks  
STARTED     114     200     220  
COMPLETED     82     156     181  
NOT COMPLETED     32     44     39  
Enrolled but not Treated                 0                 0                 1  
Efficacy Failure                 27                 39                 31  
Lost to Follow-up                 3                 3                 2  
Investigator Decision                 0                 2                 1  
Subject Withdrew Consent                 1                 0                 2  
Adverse Event                 1                 0                 1  
Study Discontinued by Sponsor                 0                 0                 1  



  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.
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.

Reporting Groups
  Description
SOF+RBV 12 Weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
SOF+RBV 24 Weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
SOF+RBV+Peg-IFN 12 Weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
Total Total of all reporting groups

Baseline Measures
    SOF+RBV 12 Weeks     SOF+RBV 24 Weeks     SOF+RBV+Peg-IFN 12 Weeks     Total  
Number of Participants  
[units: participants]
  114     200     219     533  
Age  
[units: years]
Mean (Standard Deviation)
  53  (9.6)     52  (7.6)     53  (10.0)     53  (9.1)  
Gender  
[units: participants]
       
Female     54     50     60     164  
Male     60     150     159     369  
Race/Ethnicity, Customized  
[units: participants]
       
White     105     184     187     476  
Black Or African American     4     2     20     26  
Asian     2     6     8     16  
Other     1     3     2     6  
Not Permitted     0     2     2     4  
American Indian Or Alaska Native     2     1     0     3  
Native Hawaiian Or Other Pacific Islander     0     2     0     2  
Race/Ethnicity, Customized  
[units: participants]
       
Hispanic or Latino     19     12     20     51  
Not Hispanic or Latino     95     187     197     479  
Not Permitted     0     1     2     3  
Region of Enrollment  
[units: participants]
       
United States     77     82     121     280  
United Kingdom     3     10     8     21  
Spain     1     8     2     11  
New Zealand     4     30     6     40  
Canada     7     13     10     30  
Austria     1     2     1     4  
Netherlands     2     4     4     10  
Sweden     2     5     3     10  
Czech Republic     0     0     1     1  
Poland     0     1     8     9  
Italy     3     7     4     14  
Australia     9     14     19     42  
France     2     10     11     23  
Germany     2     12     18     32  
Estonia     1     2     3     6  
HCV Genotype  
[units: participants]
       
Genotype 1     0     2     134     136  
Genotype 2     62     10     8     80  
Genotype 3     52     180     74     306  
Genotype 4     0     7     3     10  
Indeterminate     0     1     0     1  
Cirrhosis Status  
[units: participants]
       
No     89     138     183     410  
Yes     25     62     36     123  
IL28b Status [1]
[units: participants]
       
CC     38     59     47     144  
CT     61     103     127     291  
TT     13     35     40     88  
Missing     2     3     5     10  
HCV RNA  
[units: log10 IU/mL]
Mean (Standard Deviation)
  6.3  (0.87)     6.4  (0.70)     6.4  (0.64)     6.4  (0.72)  
HCV RNA Category  
[units: participants]
       
< 800,000 IU/mL     30     44     36     110  
≥ 800,000 IU/mL     84     156     183     423  
[1] CC, CT, and TT alleles are different forms of the IL28b gene.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)   [ Time Frame: Posttreatment Week 12 ]

2.  Primary:   Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event   [ Time Frame: Up to 24 weeks ]

3.  Secondary:   Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)   [ Time Frame: Posttreatment Weeks 4 and 24 ]

4.  Secondary:   Percentage of Participants With On-treatment Virologic Failure   [ Time Frame: Up to 24 weeks ]

5.  Secondary:   Percentage of Participants With Viral Relapse   [ Time Frame: Up 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
There were no limitations affecting the analysis or results.


  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
e-mail: ClinicalTrialDisclosures@gilead.com



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01625338     History of Changes
Other Study ID Numbers: GS-US-334-0109
2012-000571-16 ( EudraCT Number )
Study First Received: June 7, 2012
Results First Received: October 9, 2015
Last Updated: October 9, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Italy: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Estonia: The State Agency of Medicine
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Czech Republic: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe