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Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01682720
First received: September 5, 2012
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: October 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: 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
Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  • 475 participants were screened and 421 were randomized.
  • 419 participants were randomized and received at least 1 dose of study drug (Safety Analysis Set).
  • 334 participants with genotype 2 or 3 hepatitis C virus (HCV) infection were randomized and received at least 1 dose of sofosbuvir (Full Analysis Set).

Reporting Groups
  Description
Placebo 12 Weeks (GT2/3) Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
SOF 12 Weeks (GT2) SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
SOF 12 Weeks (GT3) SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
SOF 24 Weeks (GT3) SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.

Participant Flow:   Overall Study
    Placebo 12 Weeks (GT2/3)   SOF 12 Weeks (GT2)   SOF 12 Weeks (GT3)   SOF 24 Weeks (GT3)
STARTED   85   74   12   250 
Included in Full Analysis Set   0   73   11   250 
COMPLETED   0   69   5   211 
NOT COMPLETED   85   5   7   39 
Randomized but Not Treated                0                1                1                0 
Terminated by Sponsor                83                0                0                0 
Efficacy Failure                0                3                3                30 
Lost to Follow-up                1                1                0                6 
Subject Withdrew Consent                0                0                2                2 
Adverse Event                1                0                1                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 randomized and received at least 1 dose of study drug.

Reporting Groups
  Description
Placebo 12 Weeks (GT2/3) Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
SOF 12 Weeks (GT2) SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
SOF 12 Weeks (GT3) SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
SOF 24 Weeks (GT3) SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
Total Total of all reporting groups

Baseline Measures
   Placebo 12 Weeks (GT2/3)   SOF 12 Weeks (GT2)   SOF 12 Weeks (GT3)   SOF 24 Weeks (GT3)   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   73   11   250   419 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (10.5)   58  (10.1)   46  (8.8)   48  (10.1)   50  (10.8) 
Gender 
[Units: Participants]
         
Female   36   33   5   95   169 
Male   49   40   6   155   250 
Race/Ethnicity, Customized 
[Units: Participants]
         
Hispanic or Latino   10   6   1   36   53 
Not Hispanic or Latino   71   65   10   203   349 
Not Permitted   4   2   0   11   17 
Race/Ethnicity, Customized 
[Units: Participants]
         
Black or African American   1   5   0   0   6 
White   81   65   11   236   393 
Asian   3   1   0   9   13 
Not permitted   0   2   0   5   7 
Region of Enrollment 
[Units: Participants]
         
France   13   15   0   53   81 
Estonia   3   2   4   6   15 
Spain   11   5   1   31   48 
Poland   4   0   0   18   22 
Austria   4   2   0   12   18 
Netherlands   5   6   0   14   25 
Germany   14   8   1   46   69 
United Kingdom   17   3   4   31   55 
Italy   9   25   1   27   62 
Sweden   5   7   0   12   24 
HCV Genotype 
[Units: Participants]
         
Genotype 2   18   73   0   0   91 
Genotype 3   67   0   11   250   328 
Liver Cirrhosis 
[Units: Participants]
         
No   68   62   9   190   329 
Yes   17   11   2   60   90 
IL28b Status [1] 
[Units: Participants]
         
CC   22   24   4   86   136 
CT   49   41   4   131   225 
TT   14   8   3   33   58 
[1] CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 6.5  (0.69)   6.5  (0.70)   6.2  (0.77)   6.3  (0.74)   6.4  (0.72) 
HCV RNA Category 
[Units: Participants]
         
< 6 log10 IU/mL   21   16   4   72   113 
≥ 6 log10 IU/mL   64   57   7   178   306 
Prior HCV Treatment Experience 
[Units: Participants]
         
Experienced   50   41   9   145   245 
Naive   35   32   2   105   174 
Response to prior HCV treatment [1] 
[Units: Participants]
         
Interferon intolerant   0   3   0   10   13 
Nonresponse   18   10   4   41   73 
Relapse/Breakthrough   32   28   5   94   159 
[1] Only participants who were treatment-experienced at baseline were analyzed.
Interferon Eligibility [1] 
[Units: Participants]
         
Interferon eligible   30   27   2   94   153 
Interferon ineligible   5   5   0   11   21 
[1] Only participants who were treatment-naive at baseline were analyzed.


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Adverse Events Leading to Permanent Discontinuation of Study Drug(s)   [ Time Frame: Up to 24 weeks ]

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

4.  Secondary:   Percentage of Participants Experiencing Viral Breakthrough or 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
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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 of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01682720     History of Changes
Other Study ID Numbers: GS-US-334-0133
2012-001942-16 ( EudraCT Number )
Study First Received: September 5, 2012
Results First Received: October 2, 2014
Last Updated: October 8, 2014