Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir, sofosbuvir drug combination

Criteria

Key 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.