Author:
Camma C, et al :Gut 2002 Dec;51(6):864-869
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Date Posted: Wed, November 27 2002, 9:13:05 PST
In reply to:
Yngve T Falck-Ytter, Steedman A Sarbah, et al
's message, "SURPRISINGLY LOW IMPACT OF INTERFERON ON HEPATITIS C PATIENTS ........" on Sat, March 03 2001, 6:56:32 PST
Retreatment with interferon plus ribavirin of chronic hepatitis C non-responders to interferon monotherapy: a meta-analysis of individual patient data.
Camma C, Bruno S, Schepis F, Lo Iacono O, Andreone P, Gramenzi AG, Mangia A, Andriulli A, Puoti M, Spadaro A, Freni M, Di Marco V, Cino L, Saracco G, Chiesa A, Crosignani A, Caporaso N, Morisco F, Rumi MG, Craxi A.
Istituto Metodologie Diagnostiche Avanzate, Consiglio Nazionale delle Ricerche, and Cattedra e Unita Operativa di Gastroenterologia, University of Palermo, Palermo, Italy Istituto di Scienze Biomediche, San Paolo University of Milano, Italy Dipartimento di Medicina Sperimentale e Clinica "G Salvatore", University of Catanzaro, Italy Cattedra e Unita Operativa di Gastroenterologia, University of Palermo, Italy Dipartimento di Medicina Interna, Epatologia, University of Bologna, Italy Divisione di Gastroenterologia, Casa Sollievo della Sofferenza, S Giovanni Rotondo, Italy Clinica Malattie Infettive e Tropicali, University of Brescia, Italy Clinica Medica 1a, University of Messina, Italy Cattedra e Unita Operativa di Gastroenterologia, Ospedale Molinette, University of Torino, Italy Dipartimento di Scienze Alimentari, University Federico II of Napoli, Italy Cattedra e Unita Operativa di Gastroenterologia, IRCCS Ospedale Maggiore, University of Milano, Italy.
Background and aims:
Retreatment with a combination of alpha interferon (IFN) plus ribavirin of patients with chronic hepatitis C who did not respond to IFN monotherapy has not been assessed in large controlled studies.
METHODS:
To assess the effectiveness and tolerability of IFN/ribavirin retreatment of non-responders to IFN and to identify predictors of complete (biochemical and virological) sustained response, we performed a meta-analysis of individual data on 581 patients from 10 centres. Retreatment with various IFN schedules (mean total dose 544 mega units) and a fixed ribavirin dose (1000-1200 mg/daily depending on body weight) was given for 24-60 (mean 39.5) weeks.
RESULTS:
Biochemical end of treatment and sustained responses were observed in 271/581 (46.6%; 95% confidence interval (CI) 42.6-50.7%) and in 109/581 (18.7%; 95% CI 15.6-22.0%) cases, respectively. Two hundred and six of 532 patients (38.7%; 95% CI 34.6-42.9%) had an end of treatment complete response to retreatment while a complete sustained response occurred in 88 of 559 (15.7%; 95% CI 12.8-18.8%). Fifty four of 581 patients (9.2%; 95% CI 7.0-11.7%) stopped retreatment due to adverse effects. By logistic regression, complete sustained response was predicted independently by age <45 years (p=0.04), by normal pretreatment gamma-glutamyltransferase levels (p=0.01), and by a second course total IFN dose of at least 432 mega units (p=0.008).
CONCLUSIONS:
The overall low probability of effectiveness argues against indiscriminate retreatment of all IFN monotherapy non-responders with IFN/ribavirin. Patients less than 45 years old with normal gamma-glutamyltransferase levels who were retreated with high dose long course combination therapy had a complete sustained response rate of 30%.
PMID: 12427791 [PubMed - as supplied by publisher]
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