Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
- Registration Number
- NCT01701401
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 870
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LDV/SOF 12 weeks LDV/SOF LDV/SOF administered for 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF LDV/SOF+RBV administered for 12 weeks. LDV/SOF 24 weeks LDV/SOF LDV/SOF administered for 24 weeks LDV/SOF+RBV 24 weeks LDV/SOF LDV/SOF+RBV administered for 24 weeks. LDV/SOF+RBV 12 weeks RBV LDV/SOF+RBV administered for 12 weeks. LDV/SOF+RBV 24 weeks RBV LDV/SOF+RBV administered for 24 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) 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 Up to 24 weeks The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HCV RNA < LLOQ at Week 2 Week 2 Percentage of Participants With HCV RNA < LLOQ at Week 4 Week 4 Percentage of Participants With HCV RNA < LLOQ at Week 8 Week 8 Change From Baseline in HCV RNA at Week 2 Baseline; Week 2 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug 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.
Change From Baseline in HCV RNA at Week 4 Baseline; Week 4 Change From Baseline in HCV RNA at Week 8 Baseline; Week 8 Percentage of Participants With Virologic Failure 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