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Predictive factors of Non-Response to recombinant Interferon-Alfa 2B in patients with Chronic Hepatitis C

Author: L Viola{1}, V Perez{2}, H Tanno{6}, M Silva{3}, G Welz{4}, J Vilar{7}, N del Pino{5}, L Marangunich{5}, P Rendo{5}, JL Fernandez{5}. Clinica Suizo Argentina{1}, Instituto del Diagnostico{2}, Fundacion Favaloro{3}, Hospital Italiano{4}, Bio Sidus{5} (Buenos Aires), Hospital Centenario{6} (Rosario), and Centro de Estudios Biomedicos{7} (Corrientes), Argentina

Aim: To detect predictors of non-response to the treatment of chronic hepatitis C with recombinant interferon alfa 2b (rIFN[alpha]2b).

Patients and methods: We studied 88 patients with chronic hepatitis C and persistent ALT elevation, who received rIFN[alpha]2b (3MU 3 times a week for 24 weeks). Fifty of them were included in a randomized trial with additional administration of ursodeoxycholic acid (UDCA) (600 mg daily) or identical placebo. The following pretreatment data were analyzed as predictive factors: age, sex, transfusional origin, mean ALT, AST, [gamma]GT and alkaline phosphatase, and presence of cirrhosis in 88 cases; and mean serum ferritin, endoscopic detection of esophageal varices, and HCV genotypes (Simmonds's classification) in 50 cases. Response was considered as normalization of ALT and AST at the end of therapy and it was evaluated with an intent-to-treat analysis. Predictive factors were analyzed in patients who concluded therapy.

Results: Eighteen of the 38 non-randomized patients (47.4%), and 12 of 23 (52.2%) and 14 of 27 (51.8%) in each randomized group responded (NS). Nine patients (10.2%) did not conclude therapy because of severe side effects of rIFN[alpha]2b. When predictive factors were compared in non-responder and responder patients, mean age was 49±11 and 50±12 years (NS), male/female relationship 24/11 and 26/18 (NS), transfusional origin 29% and 23% (NS), ALT 123±68 and 119±104 mUI/ml (NS), AST 119±59 and 109±69 mUI/ml (NS), GGT 72±49 and 45±28 mUI/ml (p<0.01), alkaline phosphatase 206±99 and 189±87 mUI/ml (NS), cirrhosis 37% and 7% (p<0.001), serum ferritin 301±191 and 192±139 ng/ml (p<0.05), and esophageal varices 0 and 22% (p< 0.02). HCV genotype distribution was 1a 5 and 1 (p<0.05), 1b 10 and 15 (NS), 2a 0 and 4 (NS), 2b 1 and 3 (NS), 3a 1 and 1 (NS), 3b 1 and 1 (NS), and 4 0 and 1 (NS), respectively.

Conclusions: UDCA did not modify immediate humoral response to rIFN[alpha]2b. Cirrhosis was the main predictive factor of non-response (odds ratio at least of 2). High [gamma]GT and ferritin levels, esophageal varices and genotype 1a were also predictors of non-response.

Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting

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