Resposta sustentada após 1 ano de interferon isolado ou associado a ribavirina em pacientes com cirrose pelo vírus C

Abstract

OBJETIVO: Este trabalho teve por objetivo avaliar a taxa de resposta completa ao final do tratamento e de resposta sustentada em pacientes com cirrose pelo vírus da hepatite C tratados com interferon isolado ou combinado com ribavirina. PACIENTES E MÉTODOS: Um total de 33 pacientes cirróticos ambulatoriais, VHC positivos, sem outras causas identificáveis de doença hepática, compensados e classificados como Child-Pugh A, foram divididos em dois grupos, de forma nãorandomizada: Grupo 1 (n=13), tratado com interferon 3 MU, subcutâneo, três vezes por semana, por 12 meses; Grupo 2 (n=20), tratado com interferon na mesma posologia anterior, associado a ribavirina, 1000 mg/dia, via oral, em duas tomadas, diariamente, por 12 meses. RESULTADOS: Dos 33 pacientes, 24 (73%) eram homens e a idade variou entre 35 e 72 anos (média de 50,7 ± 9 anos). A taxa de resposta completa ao final do tratamento e de resposta sustentada foi, respectivamente, de 1/13 (8%) e 0/13 (0%) no Grupo 1 versus 11/20 (55%) e 7/20 (35%) no Grupo 2 (P<0,005). Ambos os grupos eram semelhantes quanto a idade, sexo, ferritina sérica, gamaglutamiltranspeptidase, tempo estimado de doença, grau de atividade necro-inflamatória e genótipo do VHC. Comparando-se os pacientes não-respondedores (n=26) com aqueles que obtiveram resposta sustentada (n=7), observou-se que o único fator preditivo de resposta estatisticamente significativo foi o tipo de tratamento utilizado (P<0,002). CONCLUSÕES: Pacientes ambulatoriais com cirrose compensada causada pelo VHC apresentam taxa de resposta sustentada significativamente superior quando tratados com 1 ano de interferon combinado com ribavirina, em comparação com interferon isolado pelo mesmo período. Não houve diferença estatística na freqüência de efeitos adversos entre os grupos.

OBJECTIVE: The objective of this study was to assess the rate of end of treatment complete response and sustained response in positive HCV cirrhotic patients that were either treated with interferon only, or with interferon in combination with ribavirin. PATIENTS AND METHODS: A total of 33 ambulatory HCV-positive cirrhotic patients, without any other identifiable etiology of liver disease and classified as Child-Pugh A were divided in a non-randomized manner into the following groups: Group 1 (n=13), treated with subcutaneous doses of interferon (3 UM), three times per week, for 12 months; Group 2 (n=20), treated with the same interferon schedule as described above, though associated with oral ribavirin (1000 mg/day) twice a day for 12 months. Among the 33 patients, 24 (73%) were male, and the age of all patients ranged from 35 to 72 years (mean of 50.7 + 9 years). RESULTS: The rate of end of treatment complete response and of sustained response for Group 1 was 1/13 (8%) and 0/13 (0%) respectively, versus 11/20 (55%) and 7/20 (35%) for Group 2 (P<0.005). The groups did not differ significantly with respect to age, sex, serum, serum ferritin, gamaglutamyl-transpeptidase, estimated disease duration, degree of necro-inflammatory activity, and HCV genotype. Upon comparing patients that did not present a sustained response (n=26) with patients that did present a sustained response (n=7), we observed that the only predictor of sustained response with statistical significance was the type of treatment employed (P<0.002) CONCLUSIONS: Ambulatory patients with compensated cirrhosis caused by the HCV, when submitted to the interferon and ribavirin treatment for 1 year, presented a statistically significant higher rate of sustained response than patients submitted to the interferon only treatment for the same period of time. There was no statistically significant difference between the groups in terms of frequency of side-effects.