Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
- Registration Number
- NCT02591277
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3294
Inclusion Criteria
- Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis
- Patients who are prescribed Harvoni
Key
Exclusion Criteria
- None
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Harvoni Harvoni Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reaction (ADR) under real world settings Up to 16 weeks
- Secondary Outcome Measures
Name Time Method Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24) Posttreatment Weeks 12 and 24 SVR12 and SVR24 are defined as HCV RNA \< the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks Approximately 12 weeks after treatment completion or discontinuation