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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