GS-7977 and Ribavirin in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01682720
First received: September 5, 2012
Last updated: January 31, 2014
Last verified: January 2014

September 5, 2012
January 31, 2014
September 2012
October 2013   (final data collection date for primary outcome measure)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Any adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Efficacy 12 weeks after discontinuation of therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To determine the efficacy of treatment with GS-7977 + Ribavarin (RBV) compared to treatment with GS-7977 placebo + RBV placebo as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR 12).
  • Safety and tolerability of GS-7977 + RBV. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of GS-7977 + RBV compared to placebo control as measured by review of the accumulated safety data.
Complete list of historical versions of study NCT01682720 on ClinicalTrials.gov Archive Site
  • Proportion 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 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
  • Proportion of participants experiencing viral breakthrough [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    Viral breakthrough is defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.
  • Proportion of participants experiencing viral relapse [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
  • Efficacy 4 and 24 weeks after discontinuation of therapy. [ Time Frame: 16 weeks and 36 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).
  • Efficacy of treatment with GS-7977 + RBV based on prior treatment history. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the efficacy of treatment with GS-7977 + RBV based on prior treatment history.
  • Kinetics of circulating HCV RNA during and after treatment discontinuation. [ Time Frame: 12 weeks and 36 weeks ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation.
  • Viral resistance to GS-7977 during and after treatment discontinuation. [ Time Frame: 12 weeks and 36 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
 
GS-7977 and Ribavirin in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Drug: GS-7977
    GS-7977 400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi™
    • GS-7977
    • PSI-7977
  • Drug: RBV
    Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
  • Drug: Placebo to match GS-7977
    Placebo to match GS-7977 tablet administered orally once daily
  • Drug: Placebo to match RBV
    Placebo to match RBV tablets administered orally in a divided daily dose
  • Experimental: GS-7977
    Participants with genotype 2 will receive GS-7977 plus RBV for 12 weeks and participants with genotype 3 will receive GS-7977 plus RBV for 24 weeks.
    Interventions:
    • Drug: GS-7977
    • Drug: RBV
  • Placebo Comparator: Placebo
    Participants will receive placebo to match GS-7977 and placebo to match RBV.
    Interventions:
    • Drug: Placebo to match GS-7977
    • Drug: Placebo to match RBV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
January 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 with chronic genotype 2 or 3 HCV infection.
  • HCV RNA > 10,000 IU/mL at Screening.
  • Subjects must be treatment naïve or treatment experienced.
  • Presence or absence of cirrhosis; a liver biopsy may be required.
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis.
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication.

Exclusion Criteria:

  • Prior use of any other inhibitor of the HCV NS5B Polymerase.
  • History of any other clinically significant chronic liver disease.
  • Evidence of or history of decompensated liver disease.
  • HIV or chronic hepatitis B virus (HBV) infection.
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers).
  • Chronic use of immunosuppressive agents or immunomodulatory agents.
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Estonia,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT01682720
GS-US-334-0133, 2012-001942-16
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Rob Hyland, DPhil Gilead Sciences Study Director
Gilead Sciences
January 2014

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