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)
|ClinicalTrials.gov Identifier: NCT01641640|
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Sofosbuvir Drug: RBV Drug: PEG||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||328 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||April 2013|
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: PEGASYS®
- Percentage of Participants Achieving Sustained Virologic Response (SVR)12 [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
- Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 12 ]The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
- Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ]SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
- Percentage of Participants Achieving SVR24 [ Time Frame: Posttreatment Week 24 ]SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
- Percentage of Participants With Viral Breakthrough [ Time Frame: Baseline to Week 12 ]Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
- Percentage of Participants With Viral Relapse [ Time Frame: End of treatment to post-treatment Week 24 ]Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641640
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