Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
- Registration Number
- NCT01851330
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 647
- Age > 18, with chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA > 10,000 IU/mL at screening
- 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
- Presence of cirrhosis
- Coinfection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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 8 Week LDV/SOF Participants will receive LDV/SOF FDC for 8 weeks. LDV/SOF+RBV 8 Week LDV/SOF Participants will receive LDV/SOF FDC plus RBV for 8 weeks. LDV/SOF 12 Week LDV/SOF Participants will receive LDV/SOF FDC for 12 weeks. LDV/SOF+RBV 8 Week RBV Participants will receive LDV/SOF FDC plus RBV for 8 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 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.
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug Up to 12 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 8 Week 8 Change From Baseline in HCV RNA at Week 8 Baseline; Week 8 Percentage of Participants With HCV RNA < LLOQ at Week 4 Week 4 Change From Baseline in HCV RNA at Week 4 Baseline; Week 4 Percentage of Participants With HCV RNA < LLOQ at Week 2 Week 2 Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Change From Baseline in HCV RNA at Week 2 Baseline; Week 2 Percentage of Participants Experiencing Virologic Failure Baseline to posttreatment Week 24 Virologic failure was defined as on-treatment virologic failure or virologic relapse.
* On-Treatment Virologic Failure was defined as
* Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
* Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.