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

Gilead Sciences

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Harvoni

Study type: Observational

Funder types: Industry

Identifiers

NCT02591277

GS-US-337-1498

Details and patient eligibility

About

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.

Enrollment: 3,294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

3,294 participants in 1 patient group

Harvoni

Description:

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.

Treatment:

Drug: Harvoni