Development and validation of two models for early prediction of response to therapy in genotype 1 chronic hepatitis C†

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Abstract
Early prediction of response to therapy in genotype 1 chronic hepatitis C is difficult. Two predictive models, a pretreatment scoring model (PreT‐SM) and a fourth week of therapy scoring model (4w‐SM) were constructed in a cohort of 104 patients from a single center (estimation cohort) and validated in a cohort of 141 patients from four independent centers (validation cohort). Individual scores were calculated using variables independently associated with sustained virological response (SVR). Baseline viral load, aspartate aminotransferase/alanine aminotransferase ratio, serum cholesterol, and a numerical score for noninvasive estimation of liver fibrosis were included in the PreT‐SM; HCV RNA clearance and PreT‐SM scores were included in the 4w‐SM. Receiver operating characteristic analysis revealed the area under the curve in the estimation cohort and in the validation cohort to be, respectively, 0.856 and 0.847 for the PreT‐SM and 0.908 and 0.907 for the 4w‐SM. Low scores were associated with SVR, high scores with non‐SVR. The best cutoff scores from the PreT‐SM (7 and 9.70) identified, respectively, 36% of patients with SVR and 41% of those with non‐SVR from the validation cohort, with high accuracy (≥90% positive predictive value [PPV] and specificity). Similarly, cutoff scores of 3.20 and 5.60 from the 4w‐SM identified, respectively, 71% of patients with SVR and 53% of those with non‐SVR from the same cohort with high accuracy (PPV and specificity >92%). In conclusion, these models predicted response to therapy before or after 4 weeks of treatment in approximately 60% of genotype 1 patients and may be valuable for the management of this condition. (HEPATOLOGY 2006;43:72–80.)