Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02727933

AI444-335

Details and patient eligibility

About

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

Enrollment: 1,941 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
• Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

Exclusion criteria

• Off-label use of Daklinza and Sunvepra
• Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information