[Treatment with interferon alfa-2b in patients with chronic hepatitis caused by hepatitis C virus: predictive factors for the response, relapse and early development to cirrhosis after treatment]

Abstract

The treatment of chronic hepatitis C is interferon (IFN). Diverse predictive factors influence a complete response. The aim of this study was to determine the response to IFN-alpha therapy and factors that may predict a sustained response before and after the first month of treatment. Likewise, it evaluates the relapse and liver cirrhosis evolution after therapy.

Patients and methods: We have treated 155 consecutively patients with chronic hepatitis C. Nine left therapy because of severe side effects. We studied the patients who had had persistently elevated serum aminotransferase concentrations, HBsAg negative, HIV negative and antiHCV positive with polymerase chain reaction confirmation, and without any other liver disease. The schedule of IFN-alpha 2b therapy was 5 MU three times per week for 3 months, and later, 3 MU three times per week for 6 more months. There were two groups of response: A) Complete response, if serum aminotransferase levels were normal and RNA-HCV negative, B) No response, if it didn't meet these conditions. The sustained response was complete response during follow-up. The relapse described as aminotransferase increase after suppression therapy with or without positive RNA-HCV, or positive RNA-HCV only.

Results: A complete response was obtained in 34.9%. Ten variables were statistically significant (p < 0.05) on univariate analysis: weight, corporal surface, dosage IFN/m2, bilirubin and total protein pretreatment; polymorphonuclears/mononuclears cells, AST, ALT, AST/ALT, and gamma GT in the first therapy's month. In multivariate analysis, serum AST levels < 40 U/l (odds ratio 0.15, 95% CI 0.04-0.52), and AST/ALT ratio > 0.75 (odds ratio 3.05, 95% CI 1.04-8.9) in the first month, were correlated independently with complete response. Incidence of relapse was 47% of responders, with mean appearance period a of 2.7 +/- 2.1 months. Therefore, a sustained response was obtained in 27 patients (18.5%). Seventeen of 115 patients (14.6%) without cirrhosis initially, developed liver cirrhosis after a second biopsy. Two variables were statistically significant in multiple regression analysis: RNA-HCV positive after treatment (odds ratio 2.99, 95% CI 0.9-2.99), and platelet count < 180,000/mm3 before therapy (odds ratio 17.7, 95% CI 3.7-83.2) were correlated independently with cirrhosis development.

Conclusions: A 9 months course of IFN therapy is effective in a third of patients, but almost half of them have relapsed within 6 months after treatment's suppression. The AST levels and AST/ALT ratio in the first of month therapy were correlated independently with complete response. Liver cirrhosis appears in a small percentage. Platelet count before therapy and RNA-HCV positive at the end treatment, were predictor variables of this evolution.