A survey of adverse events in 11,241 patients with chronic viral hepatitis treated with alfa interferon

Autor: Fattovich, G., Giustina, G., Favarato, S., Ruol, A., Macarri, G., Orlandi, E., Iaquinto, G., Ambrosone, L., Francavilla, A., Pastore, G., Santantonio, M. T., Romagno, D., Bolondi, L., Sofia, S., Marchesini, A., Pisi, E., Mazzella, G., Roda, E., Attaro, L., Chiodo, E., Mori, E., Verucchi, G., Lanzini, A., Salmi, A., Calvi, B., Bozzetti, E., Radaeli, E., Bernasconi, M., Pilleri, G., Bacca, D., Romano, G., Mastrapasqua, G., Cozzolongo, R., Cacopardo, B., Nunnari, A., Blasi, A., Sala, L. O., Minoli, G., Sangiovanni, A., Spinzi, G. C., Colombo, A., Camassa, M., Riva, D., Maggi, G., Boccia, S., Gualandi, G., Nucci, A., Pacini, F., Marino, N., Mazzotta, E., La Mura, A., Pompei, A. G., Casinelli, K., Petrosillo, N., Giacchino, R., Timitilli, A., Spiga, E., Corsetti, M., Menicagli, V., Tucci, A., Bissoli, E., Raimondo, G., Rodino, G., Bellobuono, A., Ideo, G., Colombo, M., Pacchetti, S., Rumi, M. R., Battezzati, P. M., Bruno, S., Podda, M., Zuin, M., Fargion, S., Fiorelli, G., Gellmann, E., Vandelli, C., Ventura, E., Manenti, F., Villa, E., Caporaso, N., Coltorti, M., Morisco, E., Del Vecchio-Blanco, C., di Santolo, S. S., Di Nunzio, S., Ruggiero, G., Zampino, R., Ascione, A., De Luca, M., Galeota-Lanza, A., Aprea, L., Sagnelli, E., Felaco, E. M., Piccinino, E., Ballare, M., Monteverde, A., Tappero, G., Sanna, G., Alberti, A., Bonetti, P., Casarin, C., Diodati, G., Tremolada, E., Naccarato, R., Chiaramonte, M., Floreani, M. R., Almasio, P., Craxi, A., Loiacono, O., Pagliaro, L., Fiaccadori, E., Giuberti, T., Belloni, G., Bernardini, E., Buscarini, L., Sbolli, G., Giudici-Cipriani, A., Marenco, G., Mazzaro, C., Massari, M., Fornaciari, G., Plancher, A., Gasbarrini, G., Grieco, A., Luchetti, R., Rapaccini, G. L., Bombardieri, G., Di Virgilio, D., Bruno, G., Ricci, G. L., Hassan, G., Mari, T., Scalisi, I., Colloredo, G., Frunzio, A., Tabone, M., Costa, C., Rosina, E., Saracco, G., Verme, G., Frezza, M., Urban, E., Capra, E., Casaril, M., Corrocher, R., Benetti, G. P.
Rok vydání: 1996
Předmět:
Zdroj: Journal of hepatology. 24(1)
ISSN: 0168-8278
Popis: Aims: The aim of this study was to assess the incidence of fatal, life-threatening side effects and the de novo appearance of non-hepatic morbidity during interferon alfa therapy for chronic viral hepatitis. The relationship of these adverse events to actual total dose and duration of interferon was also evaluated. Methods: We conducted a retrospective study at 73 Italian centers of 11 241 consecutive patients with chronic vital hepatitis who underwent interferon alfa treatment. Results: Five patients died during interferon therapy due to liver failure ( n =4) or complications arising from sepsis. Life-threatening side effects were observed in eight patients: two cases where depression developed and led to a suicide attempt and six patients with bone marrow suppression (granulocytes 3 or platelets 3 ). These symptoms and signs completely disappeared after interferon withdrawal. During interferon treatment, 131 patients developed the following de novo non-hepatic disorders: symptomatic thyroid disease ( n =71), impotence ( n =5), systemic autoimmune disease ( n =5), immune-mediated dermatologic disease ( n =14), diabetes mellitus ( n =10), cardiovascular disease ( n =7), psychosis n =10), seizures ( n =4), peripheral neuropathy ( n =3) and hemolytic anemia ( n =2). Most of these complications are reversible or can be ameliorated. Fatal or life-threatening side effects were not related to actual total dose or duration of interferon alfa, while the majority of patients with de novo non-hepatic morbidity received medium/high doses ( > 200 million units) of interferon alfa or were treated for periods longer than 16 weeks (68% and 80%, respectively). Conclusions: Treatment with interferon alfa may have fatal or life-threatening side effects, their incidence in this study being low (0.04% and 0.07%, respectively) and perhaps no different than in untreated patients with chronic viral hepatitis. Moreover de novo non-hepatic morbidity occurred in 1.2% of patients, and the dose and duration of interferon therapy seem important in determining the frequency of this complication. The development of clinically-overt thyroid disease was most common.
Databáze: OpenAIRE
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