A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
Overview
- Phase
- Phase 3
- Intervention
- LDV/SOF
- Conditions
- Chronic HCV Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 384
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to provide written informed consent
- •HCV RNA ≥ 10\^4 IU/mL at screening
- •HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
- •Genotype 1 HCV at screening
- •HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
Exclusion Criteria
- •Pregnant or nursing female
- •Chronic liver disease of a non-HCV etiology
- •Current or prior history of any clinically-significant illness (other than HCV)
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Arms & Interventions
LDV/SOF
Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.
Intervention: LDV/SOF
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL in Korea and Taiwan and \< 15 IU/mL in China) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
Secondary Outcomes
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants Experiencing Viral Relapse(Week 12 to Posttreatment Week 24)
- HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only(Baseline; Week 12)
- Percentage of Participants Experiencing Viral Breakthrough(Up to 12 weeks)