Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection (NEUTRINO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01641640
First received: July 9, 2012
Last updated: April 8, 2014
Last verified: April 2014
Results First Received: February 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Sofosbuvir
Drug: RBV
Drug: PEG

  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
Subjects were enrolled in a total of 55 study sites in the United States. The first participant was screened on 18 June 2012. The last participant observation was on 16 April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
456 participants were screened and 328 were enrolled; 327 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups
  Description
Sofosbuvir+PEG+RBV

Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.

Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.


Participant Flow:   Overall Study
    Sofosbuvir+PEG+RBV  
STARTED     328  
Enrolled and Treated     327  
COMPLETED     292  
NOT COMPLETED     36  
Enrolled but not treated                 1  
Efficacy failure                 29  
Lost to Follow-up                 3  
Withdrawal by Subject                 2  
Adverse Event                 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

Reporting Groups
  Description
Sofosbuvir+PEG+RBV

Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.

Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.


Baseline Measures
    Sofosbuvir+PEG+RBV  
Number of Participants  
[units: participants]
  327  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 10.3  
Gender  
[units: participants]
 
Female     118  
Male     209  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     46  
Not Hispanic or Latino     281  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
Black or African American     54  
White     257  
Asian     7  
American Indian/ Alaska Native/ First Nations     6  
Hawaiian or Pacific Islander     2  
Other     1  
Hepatitis C Virus (HCV) genotype  
[units: participants]
 
Genotype 1a/1b     1  
Genotype 1a     225  
Genotype 1b     66  
Genotype 4     28  
Genotype 5     1  
Genotype 6     6  
HCV RNA  
[units: log10┬áIU/mL]
Mean ± Standard Deviation
  6.4  ± 0.67  
HCV RNA Category  
[units: participants]
 
< 6 log10 IU/mL     71  
≥ 6 log10 IU/mL     256  
IL28 Genotype [1]
[units: participants]
 
CC     95  
CT     181  
TT     51  
[1] CC, CT, and TT alleles are different forms of the IL28b gene.



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Sustained Virologic Response (SVR)12   [ Time Frame: Posttreatment Week 12 ]

2.  Primary:   Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:   Percentage of Participants Achieving SVR4   [ Time Frame: Posttreatment Week 4 ]

4.  Secondary:   Percentage of Participants Achieving SVR24   [ Time Frame: Posttreatment Week 24 ]

5.  Secondary:   Percentage of Participants With Viral Breakthrough   [ Time Frame: Baseline to Week 12 ]

6.  Secondary:   Percentage of Participants With Viral Relapse   [ Time Frame: End of treatment to post-treatment 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:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01641640     History of Changes
Other Study ID Numbers: GS-US-334-0110
Study First Received: July 9, 2012
Results First Received: February 25, 2014
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration