Hepatitis C
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities | 6 months to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of AEs leading to discontinuation of study therapy | 6 months to 5 years |
| Timing of laboratory abnormalities by toxicity grade | 6 months to 5 years |
| Incidence proportion of AEs leading to discontinuation of study therapy | 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 | 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) | 24 Weeks to 36 Weeks |
Countries
South Korea
Outcome results
None listed