Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

Brief Summary

Official Title: “A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.”

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: February 2014

Interventions Used in this Clinical Trial

  • Drug: LDV/SOF
    • Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed dose combination (FDC) tablet administered orally once daily
  • Drug: RBV
    • Ribavirin (RBV) 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)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: LDV/SOF 24 weeks
    • Participants will receive LDV/SOF for 24 weeks
  • Experimental: LDV/SOF+RBV 24 weeks
    • Participants will receive LDV/SOF+RBV for 24 weeks.
  • Experimental: LDV/SOF 12 weeks
    • Participants will receive LDV/SOF for 12 weeks
  • Experimental: LDV/SOF+RBV 12 weeks
    • Participants will receive LDV/SOF+RBV for 12 weeks.

Outcome Measures for this Clinical Trial

Primary Measures

  • Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug
    • Time Frame: Posttreatment Week 12
      Safety Issue?: No
  • Incidence of any AE leading to permanent discontinuation of study
    • Time Frame: Up to 24 weeks
      Safety Issue?: No

Secondary Measures

  • Proportion of participants with SVR at 4 and 24 weeks after discontinuation of study drug
    • Time Frame: Posttreatment Weeks 4 and 24
      Safety Issue?: No
  • Proportion of participants with HCV RNA < LLOQ on treatment
    • Time Frame: Up to 24 weeks
      Safety Issue?: No
  • Change from baseline in HCV RNA
    • Time Frame: Baseline to 8 weeks of treatment
      Safety Issue?: No
  • Proportion of participants with virologic failure
    • Time Frame: Baseline to posttreatment Week 24
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Age > 18, with chronic genotype 1 HCV infection
  • HCV treatment-naive
  • HCV RNA > 10,000 IU/mL at Screening
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria

  • Pregnant or nursing female or male with pregnant female partner
  • Co-infection with HIV or HBV
  • Current or prior history of clinical hepatic decompensation
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jenny Yang, Pharm D, Study Director, Gilead Sciences

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01701401