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 Squibb1,941 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,941

Conditions

Hepatitis C

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Seoul, South Korea

Outcomes

Primary Outcomes

Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities

Time frame: 6 months to 5 years

Secondary Outcomes

Incidence proportion of AEs leading to discontinuation of study therapy

Time frame: 6 months to 5 years

Incidence rate of AEs leading to discontinuation of study therapy

Time frame: 6 months to 5 years

Timing of laboratory abnormalities by toxicity grade

Time frame: 6 months to 5 years

Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected

Time frame: 4 Weeks to 24 Weeks

The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)

Time frame: 24 Weeks to 36 Weeks

Data from ClinicalTrials.gov

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