Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2017-06-05
• Target enrollment: 0
• Participant gender: All

Summary

This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) 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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Chugai Pharmaceutical
• Treatments: Ribavirin; Sofosbuvir

Criteria

Key Inclusion Criteria:

• Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis

• Patients who are prescribed SOF+COPE

Key Exclusion Criteria:

• None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.