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

July 9, 2012
April 8, 2014
June 2012
January 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants Achieving Sustained Virologic Response (SVR)12 [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Efficacy 12 weeks post dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of patients with a sustained virologic response (SVR) 12 weeks after the end of treatment
  • The safety and tolerability of GS-7977+RBV+PEG when given for 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The safety and tolerability of GS-7977+PEG+RBV as assessed by review of the accumulated safety data
Complete list of historical versions of study NCT01641640 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ] [ Designated as safety issue: No ]
    SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
  • Percentage of Participants Achieving SVR24 [ Time Frame: Posttreatment Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 weeks and 24 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
  • Amount of circulating HCV RNA [ Time Frame: 12 weeks post dosing ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation
  • Characterization of viral resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation
Not Provided
Not Provided
 
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
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

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Sofosbuvir
    Sofosbuvir 400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977
  • 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®
Experimental: Sofosbuvir+PEG+RBV
Interventions:
  • Drug: Sofosbuvir
  • Drug: RBV
  • Drug: PEG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
April 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infection with HCV genotype 1, 4, 5, or 6
  • Cirrhosis determination
  • Subject met the following classifications:

    • Treatment-naive
    • Screening laboratory values within defined thresholds
    • Not treated with any investigational drug or device within 30 days of screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female, or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01641640
GS-US-334-0110
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP