Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01667731
First received: August 9, 2012
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
Human Immunodeficiency Virus
Interventions: Drug: SOF
Drug: RBV

  Participant Flow
  Hide Participant Flow

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 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.

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

Reporting Groups
  Description
SOF+RBV 12 Wk GT 2 TN Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
SOF+RBV 12 Wk GT 3 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF+RBV 24 Wk GT 2 TE SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
SOF+RBV 24 Wk GT 3 TE SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF+RBV 24 Wk GT 1 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)

Participant Flow:   Overall Study
    SOF+RBV 12 Wk GT 2 TN     SOF+RBV 12 Wk GT 3 TN     SOF+RBV 24 Wk GT 2 TE     SOF+RBV 24 Wk GT 3 TE     SOF+RBV 24 Wk GT 1 TN  
STARTED     26     42     24     17     115  
COMPLETED     21     26     22     15     87  
NOT COMPLETED     5     16     2     2     28  
Enrolled but not treated                 0                 0                 0                 0                 1  
Efficacy Failure                 1                 12                 0                 1                 24  
Lost to Follow-up                 2                 3                 1                 1                 2  
Subject Withdrew Consent                 2                 0                 1                 0                 1  
Death                 0                 1                 0                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Wk GT 2 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF+RBV 12 Wk GT 3 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF+RBV 24 Wk GT 2 TE SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF+RBV 24 Wk GT 3 TE SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF+RBV 24 Wk GT 1 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Total Total of all reporting groups

Baseline Measures
    SOF+RBV 12 Wk GT 2 TN     SOF+RBV 12 Wk GT 3 TN     SOF+RBV 24 Wk GT 2 TE     SOF+RBV 24 Wk GT 3 TE     SOF+RBV 24 Wk GT 1 TN     Total  
Number of Participants  
[units: participants]
  26     42     24     17     114     223  
Age  
[units: years]
Mean ± Standard Deviation
  51  ± 9.7     48  ± 9.6     54  ± 4.9     54  ± 7.0     48  ± 8.4     49  ± 8.7  
Gender  
[units: participants]
           
Female     5     8     1     3     21     38  
Male     21     34     23     14     93     185  
Ethnicity (NIH/OMB)  
[units: participants]
           
Hispanic or Latino     8     11     5     5     25     54  
Not Hispanic or Latino     18     31     19     12     89     169  
Unknown or Not Reported     0     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
           
Black or African American     6     2     6     1     37     52  
White     18     36     17     15     70     156  
Asian     0     1     1     0     1     3  
American Indian/Alaska Native/First Nations     0     0     0     1     0     1  
Hawaiian or Other Pacific Islander     1     0     0     0     1     2  
Other     1     3     0     0     5     9  
HCV Genotype  
[units: participants]
           
Genotype 1     0     0     0     0     114     114  
Genotype 2     26     0     24     0     0     50  
Genotype 3     0     42     0     17     0     59  
Liver Cirrhosis  
[units: participants]
           
No     25     36     20     11     109     201  
Yes     1     6     4     6     5     22  
IL28b Status [1]
[units: participants]
           
CC     10     15     10     10     30     75  
CT     15     22     10     7     57     111  
TT     1     5     4     0     26     36  
Missing     0     0     0     0     1     1  
HCV RNA (log10 IU/mL)  
[units: log10┬áIU/mL]
Mean ± Standard Deviation
  6.5  ± 0.59     6.2  ± 0.59     6.5  ± 0.82     6.4  ± 0.47     6.6  ± 0.83     6.5  ± 0.75  
HCV RNA Category  
[units: participants]
           
< 6 log10 IU/mL     6     15     5     2     22     50  
≥ 6 log10 IU/mL     20     27     19     15     92     173  
[1] CC, CT, and TT alleles are different forms of the IL28b gene.



  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Incidence of 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:   Change From Baseline in HCV RNA at Week 1   [ Time Frame: Baseline; Week 1 ]

5.  Secondary:   Change From Baseline in HCV RNA at Week 2   [ Time Frame: Baseline; Week 2 ]

6.  Secondary:   Change From Baseline in HCV RNA at Week 4   [ Time Frame: Baseline; Week 4 ]

7.  Secondary:   Change From Baseline in HCV RNA at Week 6   [ Time Frame: Baseline; Week 6 ]

8.  Secondary:   Change From Baseline in HCV RNA at Week 8   [ Time Frame: Baseline; Week 8 ]

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

10.  Secondary:   Percentage of Participants Experiencing Viral Relapse   [ Time Frame: Up to Posttreatment Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01667731     History of Changes
Other Study ID Numbers: GS-US-334-0123
Study First Received: August 9, 2012
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration