Does the Grade of Inflammation on Liver Biopsy Predict the Response to Combination Treatment with Pegylated Interferon and Ribavirin in Hepatitis C Patients?

Extent of liver inflammation in predicting response to interferon α & Ribavirin in chronic hepatitis C patients: a cohort study

“…Sample size was calculated using the software ‘Sample size determination in health studies-A practical manual’ version 2.0 (WHO) [ 16 ]. Taking proportion of disease (non responders, Qualitative PCR for HCH RNA positive) in exposed (high grades of inflammation) at the end of therapy as 40% [ 12 ], anticipated Relative Risk (RR) as 1.5, level of significance as 5% and power as 80%, at least 196 patients were required in each inflammation group. Taking the ratio of High to Low grades of liver inflammation as 1:4 [ 13 ], and anticipated missing data as 10%, at least 137 patients were required with high grades and 545 required with low grades of liver inflammation.…”

“…Few studies report whether histological variables other than fibrosis on liver biopsy, like grade of inflammation, can predict the response to antiviral therapy in CHC patients, showing conflicting results. Study by Daboul I et al in Ohio, USA showed that response at 12 weeks (EVR positive) in CHC patients with high grades of liver inflammation was 60% compared to 68% in those with low grades when treated with Pegylated Interferon and Ribavirin [ 12 ]. Another study in the Middle East reported positive correlation between response rate after 24 weeks of stopping the therapy (SVR positive) and liver inflammation [ 13 ].…”

“…Another study in the Middle East reported positive correlation between response rate after 24 weeks of stopping the therapy (SVR positive) and liver inflammation [ 13 ]. The former was conducted in HCV genotype 1 [ 12 ] and the latter in HCV genotype 4 patients [ 13 ]. Moreover, both studies have small sample size affecting the internal validity.…”