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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701401
First Posted: October 5, 2012
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
October 2, 2012
October 5, 2012
March 17, 2015
March 27, 2015
March 27, 2015
September 2012
March 2014   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.
  • Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug [ Time Frame: Up to 24 weeks ]
    The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
  • Sustained virologic response after discontinuation of therapy. [ Time Frame: 12 weeks after discontinuation of therapy. ]
    Sustained virologic response (SVR) 12 weeks after the end of treatment (SVR12 defined as HCV RNA < lower limit of quantification [LLOQ] 12 weeks after last dose of study drug).
  • Safety and tolerability of combination treatment with sofosbuvir (SOF)/GS-5885 fixed-dose combination (FDC) +/- RBV as measured by review of the accumulated safety data. [ Time Frame: Safety and tolerability on treatment and 30 days post last dose. ]
    Frequency and severity of adverse events.
Complete list of historical versions of study NCT01701401 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.
  • Percentage of Participants With HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
  • Percentage of Participants With HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
  • Percentage of Participants With HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
  • Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
  • Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
  • Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
  • Percentage of Participants With Virologic Failure [ Time Frame: Baseline to posttreatment Week 24 ]

    On-treatment virologic failure was defined as:

    • Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR
    • Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR
    • Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

    Virologic 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

  • Sustained virologic response after discontinuation of therapy. [ Time Frame: 4 and 24 weeks after discontinuation of therapy. ]
    Sustained virologic response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24 defined as HCV RNA < lower limit of quantification [LLOQ] 12 weeks after last dose of study drug).
  • Kinetics of circulating HCV RNA during and after treatment discontinuation. [ Time Frame: 12 and 24 weeks ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation.
  • Viral resistance to sofosbuvir and GS-5885 combination therapy during and after treatment. [ Time Frame: 12 and 24 weeks ]
    To evaluate the emergence of viral resistance to sofosbuvir and GS-5885 during treatment and after treatment discontinuation.
  • Characterization of steady state pharmacokinetics of sofosbuvir and GS-5885 during treatment and after treatment discontinuation. [ Time Frame: 12 and 24 weeks. ]
    To characterize steady state pharmacokinetics of sofosbuvir and GS-5885 during treatment and after treatment discontinuation.
Not Provided
Not Provided
 
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis C Virus
  • Drug: LDV/SOF
    LDV/SOF 90/400 mg FDC tablet administered orally once daily
    Other Names:
    • Harvoni®
    • GS-5885/GS-7977
  • Drug: RBV
    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)
  • Experimental: LDV/SOF 12 weeks
    LDV/SOF administered for 12 weeks
    Intervention: Drug: LDV/SOF
  • Experimental: LDV/SOF+RBV 12 weeks
    LDV/SOF+RBV administered for 12 weeks.
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: LDV/SOF 24 weeks
    LDV/SOF administered for 24 weeks
    Intervention: Drug: LDV/SOF
  • Experimental: LDV/SOF+RBV 24 weeks
    LDV/SOF+RBV administered for 24 weeks.
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
870
April 2014
March 2014   (Final data collection date for primary outcome measure)

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 hepatitis B virus (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Puerto Rico,   Spain,   United Kingdom,   United States
 
 
NCT01701401
GS-US-337-0102
2012-003387-43 ( EudraCT Number )
Yes
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Jenny Yang, Pharm D Gilead Sciences
Gilead Sciences
March 2015

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