Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response.
- Conditions
- Chronic hepatitis C patients of genotype 1
- Registration Number
- JPRN-UMIN000009656
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
The rates of undetectable HCV RNA at week 4 (RVR) and at 24 weeks after therapy (sustained virological response: SVR) were 71.4% and 82.9%, respectively. Of patients with RVR, 90% achieved an SVR. The mean TVR C-troughs at days 3 and 7 and weeks 2 and 8 of SVR patients (2748.2, 2733.7, 2999.0, and 2937.8 ng/mL, respectively) was significantly higher than that of non-SVR patients (1616.4, 1788.0, 2314.4, and 2691.1 ng/mL, respectively) (all P<0.05). Multiple logistic regression analysis identified two factors: higher TVR C-trough at day 3 (ng/mL) (odds ratio 1.012, P<0.0001) and prior treatment relapse (odds ratio 6.16 for prior null response, P<0.0001).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
Exclusion criteria were: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation (ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (autoimmune hepatitis, primary biliary cirrhosis, or steatohepatitis); (4) excessive active alcohol consumption (a daily intake of more than 40 g of ethanol) or drug abuse; (5) suspected HCC at entry; or (6) treatment with antiviral or immunosuppressive agents prior to enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method