A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 554
- Primary Endpoint
- Incidence of adverse drug reaction (ADR) under real world settings
Study Overview
Brief Summary
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
- •Patients who are prescribed SOF+REB
Exclusion Criteria
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
SOF+REB
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
Intervention: SOF (Drug)
SOF+REB
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
Intervention: REB (Drug)
Outcomes
Primary Outcomes
Incidence of adverse drug reaction (ADR) under real world settings
Time Frame: Up to 16 weeks
Secondary Outcomes
- Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)(Posttreatment Weeks 12 and 24)
- Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks(Approximately 12 weeks after treatment completion or discontinuation)