Hepatitis C, Chronic
Conditions
Brief summary
To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C patients receiving directly acting antivirals in Taiwan
Detailed description
The National Health Insurance Administration (NHIA) in Taiwan supports the use of antivirals against CHC. Recently, the introduction of directly acting antivirals (DAA) has markedly improved the treatment adherence, efficacy and safety issues in well-designed clinical trials. However, the real world community effectiveness and long-term benefits of DAA for HCV treatments remain to be determined. Since the NHIA in Taiwan has reimbursed the DAA in the treatment of chronic hepatitis C (CHC) patients in the near future, establishment of a well prospectively designed registry policy is demanded in the national level to explore the unmet needs of HCV control in Taiwan. The primary purpose of the study is to establish a nationwide registry of patients undergoing antiviral treatment with DAA regimens for CHC at both academic and community practices. Based on this database, the clinical gaps regarding to treatment guidelines and management of adverse events will be identified. The registry system will be established as a research network and provide sufficient high-quality clinical information for investigators in Taiwan.
Interventions
OTHERdirectly acting antivirals (DAAs)
Eligible subjects would be those CHC patients who receive approved DAA in the daily practice in Taiwan. No clinical developing medications will be allocated patients.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
1\. Patients who are treated with DAA and have willingness to participate in this registry.
Exclusion criteria
Chronic hepatitis C patients who are unwilling to participate in the study and do not provide written informed consent for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients who have successfully eradicated HCV by DAAs | 12 months | To determine the treatment efficacy, defined as undetectable HCV RNA 12 weeks after end of therapy (sustained virological response 12 weeks after treatment, SVR12) of chronic hepatitis C patients receiving directly acting antivirals |
Countries
Taiwan
Contacts
Primary ContactMing-Lung Yu, MD., PhD
Outcome results
None listed