Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
- Registration Number
- NCT01726517
- 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 of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Age ≥ 18 years, with chronic genotype 1 HCV infection
- HCV RNA equal to or greater than 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
- 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 8 Weeks (TN) LDV/SOF Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks. LDV/SOF+RBV 8 Weeks (TN) LDV/SOF Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks. LDV/SOF 12 Weeks (TN) LDV/SOF Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks. LDV/SOF 12 Weeks (TE) LDV/SOF Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor \[PI\]+pegylated interferon \[PEG\]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks. LDV/SOF+RBV 12 Weeks (TE) LDV/SOF Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks. LDV/SOF+RBV 8 Weeks (TN) RBV Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks. LDV/SOF+RBV 12 Weeks (TE) RBV Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) at 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 after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) Baseline to Week 12 The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) Posttreatment Weeks 2, 4, 8, and 24 SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA \< LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse Baseline to Posttreatment Week 24 * Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
* Viral 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.