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ITPA polymorphism effects on decrease of hemoglobin during sofosbuvir and ribavirin combination treatment for chronic hepatitis C

Not Applicable
Conditions
chronic hepatitis C
Registration Number
JPRN-UMIN000023086
Lead Sponsor
Hiroshima University
Brief Summary

Overall, SVR12 was achieved in 231 (94.7%) patients, based on intention to treat analysis. During the therapy, reduction of hemoglobin levels was significantly greater in ITPA genotype CC patients than CA/AA patients. Therefore, the cumulative proportion of patients with RBV dose reduction was significantly higher and total dose of RBV was significantly lower in patients with CC genotype compared to CA/AA genotypes. SVR12 rates were similar between ITPA genotype CC and CA/AA (94.7% and 94.4%, respectively, P=0.933). Multivariate logistic regression analysis identified FIB4 index <3.25 (OR, 9.388 for >3.25; P=0.005) and low body weight (OR, 1.059, for high body weight; P=0.017) as independent predictors for SVR12.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
500
Inclusion Criteria

Not provided

Exclusion Criteria

Patients with decompensated cirrhosis

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sustained virological response (negative for serum HCV RNA at 24 weeks after the treatment)
Secondary Outcome Measures
NameTimeMethod
Hemoglobin during the treatment period
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