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 viral 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 <500/ mm3 or platelets <25 000/mm3). 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.
A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon / 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.. - In: JOURNAL OF HEPATOLOGY. - ISSN 0168-8278. - 24:1(1996), pp. 38-47. [10.1016/S0168-8278(96)80184-X]
A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon
Mori E.;Mastrapasqua G.;Blasi A.;Riva D.;Gualandi G.;Tucci A.;Raimondo G.;Rodino G.;Bruno S.;Fargion S.;Vandelli C.;Manenti F.;Villa E.;Ruggiero G.;Pagliaro L.;Massari M.;Grieco A.;Saracco G.;
1996
Abstract
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 viral 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 <500/ mm3 or platelets <25 000/mm3). 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.
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