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

Gilead Sciences

Status: Completed

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF; Drug: COPE

Study type: Observational

Funder types: Industry

Identifiers

NCT02537379

GS-US-334-1444 / COPE1501

Details and patient eligibility

About

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.

Enrollment: 552 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

552 participants in 1 patient group

SOF+COPE

Description:

Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE as part of routine clinical care at a participating clinical site.

Treatment:

Drug: COPE

Drug: SOF