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Sofosbuvir 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: October 8, 2014
Last verified: October 2014

September 5, 2012
October 8, 2014
September 2012
October 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ 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 following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
  • Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
  • 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
  • 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 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
  • Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]

    Viral breakthrough was 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.

    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

    Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

  • 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
 
Sofosbuvir 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: SOF
    Sofosbuvir (SOF) 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 SOF
    Placebo to match SOF administered orally once daily
  • Drug: Placebo to match RBV
    Placebo to match RBV administered orally in a divided daily dose
  • Placebo Comparator: Placebo 12 Weeks (GT2/3)
    Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
    Interventions:
    • Drug: Placebo to match SOF
    • Drug: Placebo to match RBV
  • Experimental: SOF 12 Weeks (GT2/3)
    Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
    Interventions:
    • Drug: SOF
    • Drug: RBV
  • Experimental: SOF 24 Weeks (GT3)
    SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
    Interventions:
    • Drug: SOF
    • Drug: RBV
Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hézode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.

*   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 naive 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
October 2014

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