Effectiveness and safety of simeprevir-basd triple therapy for chronic hepatitis C in multicenter study
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000014568
- Lead Sponsor
- The Kyushu Univerisity Liver Disease Study Group
- Brief Summary
Simeprevir-based triple therapy have a lower risk of the development of severe anemia than telaprevir-based therapy. ITPA genotype and age are useful for individualizing treatment to reduce the risk of anemia-related adverse effects. Simeprevir-based triple therapy will continue to be a useful treatment option for treatment-naive or prior relapse patients with a favorable IL28B genotype (SVR>90%).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Not provided
(1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen (2) clinical or biochemical evidence of hepatic decompensation (Child-Pugh B or C, ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (hemochromatosis, autoimmune hepatitis, or primary biliary cirrhosis) (4) excessive active alcohol consumption (a daily intake of more than 40g of ethanol), drug abuse or severe mental disorder (5) the presence of active cancer at entry (6) experienced treatment with telaprevir
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained viral response (SVR)
- Secondary Outcome Measures
Name Time Method Factors associated with SVR Adverse effects (anemia) Efficacy and safety for older patients