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

Giovanna Fattovich, Giuliano Giustina, Susanna Favarato, Arturo Ruol, G. Macarri, E. Orlandi, G. Iaquinto, L. Ambrosone, A. Francavilla, G. Pastore, M. T. Santantonio, D. Romagno, L. Bolondi, S. Sofia, A. Marchesini, E. Pisi, G. Mazzella, E. Roda, L. Attaro, E. Chiodo & 126 others E. Mori, G. Verucchi, A. Lanzini, A. Salmi, B. Calvi, E. Bozzetti, E. Radaeli, M. Bernasconi, G. Pilleri, D. Bacca, G. Romano, G. Mastrapasqua, R. Cozzolongo, B. Cacopardo, A. Nunnari, A. Blasi, L. O. Sala, G. Minoli, A. Sangiovanni, G. C. Spinzi, A. Colombo, M. Camassa, D. Riva, G. Maggi, S. Boccia, G. Gualandi, A. Nucci, F. Pacini, N. Marino, E. Mazzotta, A. La Mura, A. G. Pompei, K. Casinelli, N. Petrosillo, R. Giacchino, A. Timitilli, E. Spiga, M. Corsetti, V. Menicagli, A. Tucci, E. Bissoli, G. Raimondo, G. Rodino, A. Bellobuono, G. Ideo, M. Colombo, S. Pacchetti, M. R. Rumi, P. M. Battezzati, S. Bruno, M. Podda, M. Zuin, S. Fargion, G. Fiorelli, E. Gellmann, C. Vandelli, E. Ventura, F. Manenti, E. Villa, N. Caporaso, M. Coltorti, E. Morisco, C. Del Vecchio-Blanco, S. Scotto di Santolo, S. Di Nunzio, G. Ruggiero, R. Zampino, A. Ascione, M. De Luca, A. Galeota-Lanza, L. Aprea, E. Sagnelli, E. M. Felaco, E. Piccinino, M. Ballare, A. Monteverde, G. Tappero, G. Sanna, A. Alberti, P. Bonetti, C. Casarin, G. Diodati, E. Tremolada, R. Naccarato, M. Chiaramonte, M. R. Floreani, P. Almasio, A. Craxi, O. Loiacono, L. Pagliaro, E. Fiaccadori, T. Giuberti, G. Belloni, E. Bernardini, L. Buscarini, G. Sbolli, A. Giudici-Cipriani, G. Marenco, C. Mazzaro, M. Massari, G. Fornaciari, A. Plancher, G. Gasbarrini, A. Grieco, R. Luchetti, G. L. Rapaccini, G. Bombardieri, D. Di Virgilio, G. Bruno, G. L. Ricci, G. Hassan, T. Mari, I. Scalisi, G. Colloredo, A. Frunzio, M. Tabone, C. Costa, E. Rosina, G. Saracco, G. Verme, M. Frezza, E. Urban, E. Capra, M. Casaril, R. Corrocher, G. P. Benetti

Research output: Contribution to journalArticle

449 Citations (Scopus)

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 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.

Original languageEnglish
Pages (from-to)38-47
Number of pages10
JournalJournal of Hepatology
Volume24
Issue number1
DOIs
Publication statusPublished - Jan 1 1996

Fingerprint

Chronic Hepatitis
Interferon-alpha
Interferons
Thyroid Diseases
Morbidity
Therapeutics
Surveys and Questionnaires
Hemolytic Anemia
Liver Failure
Peripheral Nervous System Diseases
Erectile Dysfunction
Granulocytes
Psychotic Disorders
Suicide
Autoimmune Diseases
Signs and Symptoms
Sepsis
Diabetes Mellitus
Seizures
Cohort Studies

Keywords

  • Chronic viral hepatitis
  • Interferon alfa
  • Side effects

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Fattovich, G., Giustina, G., Favarato, S., Ruol, A., Macarri, G., Orlandi, E., ... Benetti, G. P. (1996). A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon. Journal of Hepatology, 24(1), 38-47. https://doi.org/10.1016/S0168-8278(96)80184-X

A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon. / Fattovich, Giovanna; Giustina, Giuliano; Favarato, Susanna; Ruol, Arturo; 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. Scotto; 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, Vol. 24, No. 1, 01.01.1996, p. 38-47.

Research output: Contribution to journalArticle

Fattovich, G, Giustina, G, Favarato, S, Ruol, A, Macarri, G, Orlandi, E, Iaquinto, G, Ambrosone, L, Francavilla, A, Pastore, G, Santantonio, MT, 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, LO, Minoli, G, Sangiovanni, A, Spinzi, GC, Colombo, A, Camassa, M, Riva, D, Maggi, G, Boccia, S, Gualandi, G, Nucci, A, Pacini, F, Marino, N, Mazzotta, E, La Mura, A, Pompei, AG, 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, MR, Battezzati, PM, 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, SS, Di Nunzio, S, Ruggiero, G, Zampino, R, Ascione, A, De Luca, M, Galeota-Lanza, A, Aprea, L, Sagnelli, E, Felaco, EM, 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, MR, 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, GL, Bombardieri, G, Di Virgilio, D, Bruno, G, Ricci, GL, 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, GP 1996, 'A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon', Journal of Hepatology, vol. 24, no. 1, pp. 38-47. https://doi.org/10.1016/S0168-8278(96)80184-X
Fattovich, Giovanna ; Giustina, Giuliano ; Favarato, Susanna ; Ruol, Arturo ; 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. Scotto ; 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. / A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon. In: Journal of Hepatology. 1996 ; Vol. 24, No. 1. pp. 38-47.
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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 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.",
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author = "Giovanna Fattovich and Giuliano Giustina and Susanna Favarato and Arturo Ruol and G. Macarri and E. Orlandi and G. Iaquinto and L. Ambrosone and A. Francavilla and G. Pastore and Santantonio, {M. T.} and D. Romagno and L. Bolondi and S. Sofia and A. Marchesini and E. Pisi and G. Mazzella and E. Roda and L. Attaro and E. Chiodo and E. Mori and G. Verucchi and A. Lanzini and A. Salmi and B. Calvi and E. Bozzetti and E. Radaeli and M. Bernasconi and G. Pilleri and D. Bacca and G. Romano and G. Mastrapasqua and R. Cozzolongo and B. Cacopardo and A. Nunnari and A. Blasi and Sala, {L. O.} and G. Minoli and A. Sangiovanni and Spinzi, {G. C.} and A. Colombo and M. Camassa and D. Riva and G. Maggi and S. Boccia and G. Gualandi and A. Nucci and F. Pacini and N. Marino and E. Mazzotta and {La Mura}, A. and Pompei, {A. G.} and K. Casinelli and N. Petrosillo and R. Giacchino and A. Timitilli and E. Spiga and M. Corsetti and V. Menicagli and A. Tucci and E. Bissoli and G. Raimondo and G. Rodino and A. Bellobuono and G. Ideo and M. Colombo and S. Pacchetti and Rumi, {M. R.} and Battezzati, {P. M.} and S. Bruno and M. Podda and M. Zuin and S. Fargion and G. Fiorelli and E. Gellmann and C. Vandelli and E. Ventura and F. Manenti and E. Villa and N. Caporaso and M. Coltorti and E. Morisco and {Del Vecchio-Blanco}, C. and {di Santolo}, {S. Scotto} and {Di Nunzio}, S. and G. Ruggiero and R. Zampino and A. Ascione and {De Luca}, M. and A. Galeota-Lanza and L. Aprea and E. Sagnelli and Felaco, {E. M.} and E. Piccinino and M. Ballare and A. Monteverde and G. Tappero and G. Sanna and A. Alberti and P. Bonetti and C. Casarin and G. Diodati and E. Tremolada and R. Naccarato and M. Chiaramonte and Floreani, {M. R.} and P. Almasio and A. Craxi and O. Loiacono and L. Pagliaro and E. Fiaccadori and T. Giuberti and G. Belloni and E. Bernardini and L. Buscarini and G. Sbolli and A. Giudici-Cipriani and G. Marenco and C. Mazzaro and M. Massari and G. Fornaciari and A. Plancher and G. Gasbarrini and A. Grieco and R. Luchetti and Rapaccini, {G. L.} and G. Bombardieri and {Di Virgilio}, D. and G. Bruno and Ricci, {G. L.} and G. Hassan and T. Mari and I. Scalisi and G. Colloredo and A. Frunzio and M. Tabone and C. Costa and E. Rosina and G. Saracco and G. Verme and M. Frezza and E. Urban and E. Capra and M. Casaril and R. Corrocher and Benetti, {G. P.}",
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TY - JOUR

T1 - A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon

AU - Fattovich, Giovanna

AU - Giustina, Giuliano

AU - Favarato, Susanna

AU - Ruol, Arturo

AU - Macarri, G.

AU - Orlandi, E.

AU - Iaquinto, G.

AU - Ambrosone, L.

AU - Francavilla, A.

AU - Pastore, G.

AU - Santantonio, M. T.

AU - Romagno, D.

AU - Bolondi, L.

AU - Sofia, S.

AU - Marchesini, A.

AU - Pisi, E.

AU - Mazzella, G.

AU - Roda, E.

AU - Attaro, L.

AU - Chiodo, E.

AU - Mori, E.

AU - Verucchi, G.

AU - Lanzini, A.

AU - Salmi, A.

AU - Calvi, B.

AU - Bozzetti, E.

AU - Radaeli, E.

AU - Bernasconi, M.

AU - Pilleri, G.

AU - Bacca, D.

AU - Romano, G.

AU - Mastrapasqua, G.

AU - Cozzolongo, R.

AU - Cacopardo, B.

AU - Nunnari, A.

AU - Blasi, A.

AU - Sala, L. O.

AU - Minoli, G.

AU - Sangiovanni, A.

AU - Spinzi, G. C.

AU - Colombo, A.

AU - Camassa, M.

AU - Riva, D.

AU - Maggi, G.

AU - Boccia, S.

AU - Gualandi, G.

AU - Nucci, A.

AU - Pacini, F.

AU - Marino, N.

AU - Mazzotta, E.

AU - La Mura, A.

AU - Pompei, A. G.

AU - Casinelli, K.

AU - Petrosillo, N.

AU - Giacchino, R.

AU - Timitilli, A.

AU - Spiga, E.

AU - Corsetti, M.

AU - Menicagli, V.

AU - Tucci, A.

AU - Bissoli, E.

AU - Raimondo, G.

AU - Rodino, G.

AU - Bellobuono, A.

AU - Ideo, G.

AU - Colombo, M.

AU - Pacchetti, S.

AU - Rumi, M. R.

AU - Battezzati, P. M.

AU - Bruno, S.

AU - Podda, M.

AU - Zuin, M.

AU - Fargion, S.

AU - Fiorelli, G.

AU - Gellmann, E.

AU - Vandelli, C.

AU - Ventura, E.

AU - Manenti, F.

AU - Villa, E.

AU - Caporaso, N.

AU - Coltorti, M.

AU - Morisco, E.

AU - Del Vecchio-Blanco, C.

AU - di Santolo, S. Scotto

AU - Di Nunzio, S.

AU - Ruggiero, G.

AU - Zampino, R.

AU - Ascione, A.

AU - De Luca, M.

AU - Galeota-Lanza, A.

AU - Aprea, L.

AU - Sagnelli, E.

AU - Felaco, E. M.

AU - Piccinino, E.

AU - Ballare, M.

AU - Monteverde, A.

AU - Tappero, G.

AU - Sanna, G.

AU - Alberti, A.

AU - Bonetti, P.

AU - Casarin, C.

AU - Diodati, G.

AU - Tremolada, E.

AU - Naccarato, R.

AU - Chiaramonte, M.

AU - Floreani, M. R.

AU - Almasio, P.

AU - Craxi, A.

AU - Loiacono, O.

AU - Pagliaro, L.

AU - Fiaccadori, E.

AU - Giuberti, T.

AU - Belloni, G.

AU - Bernardini, E.

AU - Buscarini, L.

AU - Sbolli, G.

AU - Giudici-Cipriani, A.

AU - Marenco, G.

AU - Mazzaro, C.

AU - Massari, M.

AU - Fornaciari, G.

AU - Plancher, A.

AU - Gasbarrini, G.

AU - Grieco, A.

AU - Luchetti, R.

AU - Rapaccini, G. L.

AU - Bombardieri, G.

AU - Di Virgilio, D.

AU - Bruno, G.

AU - Ricci, G. L.

AU - Hassan, G.

AU - Mari, T.

AU - Scalisi, I.

AU - Colloredo, G.

AU - Frunzio, A.

AU - Tabone, M.

AU - Costa, C.

AU - Rosina, E.

AU - Saracco, G.

AU - Verme, G.

AU - Frezza, M.

AU - Urban, E.

AU - Capra, E.

AU - Casaril, M.

AU - Corrocher, R.

AU - Benetti, G. P.

PY - 1996/1/1

Y1 - 1996/1/1

N2 - 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 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.

AB - 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 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.

KW - Chronic viral hepatitis

KW - Interferon alfa

KW - Side effects

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U2 - 10.1016/S0168-8278(96)80184-X

DO - 10.1016/S0168-8278(96)80184-X

M3 - Article

VL - 24

SP - 38

EP - 47

JO - Journal of Hepatology

JF - Journal of Hepatology

SN - 0168-8278

IS - 1

ER -