A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 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:
NCT01783678
First received: January 31, 2013
Last updated: April 15, 2015
Last verified: April 2015
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Hepatitis C
Human Immunodeficiency Virus
Interventions: Drug: Sofosbuvir
Drug: 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 39 study sites in Australia and Europe. The first participant was screened on 18 January 2013. The last study visit occurred on 10 July 2014.

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

Reporting Groups
  Description
Genotype 2 Treatment-naive Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
Genotype 1 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
Genotype 2 Treatment-experienced SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
Genotype 3 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
Genotype 3 Treatment-experienced SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
Genotype 4 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection

Participant Flow:   Overall Study
    Genotype 2 Treatment-naive     Genotype 1 Treatment-naive     Genotype 2 Treatment-experienced     Genotype 3 Treatment-naive     Genotype 3 Treatment-experienced     Genotype 4 Treatment-naive  
STARTED     19     112     6     58     49     31  
COMPLETED     17     94     5     50     42     26  
NOT COMPLETED     2     18     1     8     7     5  
Randomized but Not Treated                 0                 0                 0                 1                 0                 0  
Lack of Efficacy                 1                 13                 1                 3                 6                 5  
Lost to Follow-up                 0                 4                 0                 2                 1                 0  
Withdrew Consent                 1                 1                 0                 2                 0                 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.
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug

Reporting Groups
  Description
Genotype 2 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
Genotype 1 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
Genotype 2 Treatment-experienced SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
Genotype 3 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
Genotype 3 Treatment-experienced SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
Genotype 4 Treatment-naive SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
Total Total of all reporting groups

Baseline Measures
    Genotype 2 Treatment-naive     Genotype 1 Treatment-naive     Genotype 2 Treatment-experienced     Genotype 3 Treatment-naive     Genotype 3 Treatment-experienced     Genotype 4 Treatment-naive     Total  
Number of Participants  
[units: participants]
  19     112     6     57     49     31     274  
Age  
[units: years]
Mean (Standard Deviation)
  55  (8.2)     45  (7.6)     55  (10.2)     47  (5.4)     49  (6.2)     47  (5.9)     47  (7.4)  
Gender  
[units: participants]
             
Female     4     12     0     19     11     7     53  
Male     15     100     6     38     38     24     221  
Race/Ethnicity, Customized  
[units: participants]
             
Black or African American     0     1     1     0     0     1     3  
White     18     104     5     54     49     29     259  
Asian     0     5     0     2     0     0     7  
American Indian/Alaska Native/First Nations     1     0     0     0     0     0     1  
Other     0     1     0     1     0     0     2  
Not Permitted     0     1     0     0     0     1     2  
Race/Ethnicity, Customized  
[units: participants]
             
Hispanic or Latino     3     4     0     3     5     1     16  
Not Hispanic or Latino     16     106     6     54     44     29     255  
Not Permitted     0     2     0     0     0     1     3  
Cirrhosis Status  
[units: participants]
             
No     18     95     4     54     26     23     220  
Yes     1     17     2     3     23     8     54  
IL28b Status [1]
[units: participants]
             
CC     12     48     3     30     25     9     127  
CT     5     45     1     21     20     14     106  
TT     2     18     2     6     4     8     40  
Missing     0     1     0     0     0     0     1  
Hepatitis C Virus (HCV) RNA  
[units: log10┬áIU/mL]
Mean (Standard Deviation)
  6.7  (0.66)     6.3  (0.72)     6.4  (0.62)     6.3  (0.71)     6.3  (0.77)     5.9  (0.85)     6.3  (0.75)  
HCV RNA Category  
[units: participants]
             
< 6 log10 IU/mL     2     33     1     21     12     12     81  
≥ 6 log10 IU/mL     17     79     5     36     37     19     193  
[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:   HCV RNA Change From Baseline at Week 1   [ Time Frame: Baseline; Week 1 ]

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

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

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

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

9.  Secondary:   Percentage of Participants Experiencing Virologic Failure   [ Time Frame: Baseline 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


No publications provided by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01783678     History of Changes
Other Study ID Numbers: GS-US-334-0124
Study First Received: January 31, 2013
Results First Received: April 15, 2015
Last Updated: April 15, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
European Union: European Medicines Agency