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1. Hepatitis C in the elderly: a multicentre cross-sectional study by the Italian Association for the Study of the Liver

Author

Gramenzi, A, Conti, F, Cammà, C, Grieco, A, Picciotto, A, Furlan, C, Romagno, D, Costa, P, Rendina, M, Ancarani, F, Chiaramonte, Maria, Verucchi, G, Craxì, A, Bernardi, M, Andreone, P, Floreani, Annarosa, Basso, Monica, Gramenzi, A, Conti, F, Cammà, C, Grieco, A, Picciotto, A, Furlan, C, Romagno, D, Costa, P, Rendina, M, Ancarani, F, Chiaramonte, M, Verucchi, G, Craxi, A, Bernardi, M, Andreone, P, Gramenzi A, Conti F, Cammà C, Grieco A, Picciotto A, Furlan C, Romagno D, Rendina M, Chiaramonte M, Verucchi G, Craxi A, Bernardi M, and Andreone P.

Subjects
Liver Cirrhosis, Male, AGED PATIENTS, EPIDEMIOLOGY, HCV INFECTION, LIVER DISEASES, ANTI-VIRAL TREATMENT, Epidemiology, Cross-sectional study, Hepacivirus, medicine.disease_cause, Liver disease, 80 and over, Prevalence, Chronic, Aged patients, Aged, 80 and over, education.field_of_study, hepatitis c elderly italy, Age Factors, Gastroenterology, liver diseases, hcv infection, epidemiology, aged patients, Alanine Transaminase, Hepatitis C, Viral Load, HCV infection, Italy, HCV, Liver diseases, Population study, Female, Viral load, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, Hepatitis C virus, Population, geriatric, Antiviral Agents, Internal medicine, medicine, Humans, education, Settore MED/42 - IGIENE GENERALE E APPLICATA, Aged, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Hepatitis C, Chronic, Hepatitis C Antibodies, medicine.disease, Surgery, Cross-Sectional Studies, business
Abstract

Background: The prevalence of hepatitis C virus infection increases with advancing age, but elderly hepatitis C virus patients remain an understudied population. Aim: To define the virological, epidemiological and clinical profiles of Italian outpatients aged 65 years and over infected by hepatitis C virus. Methods: We evaluated 1544 anti-hepatitis C virus positive patients aged >=65 years referred to 34 Italian outpatient specialty clinics over a two-year period. Results: The study population included 1134 (73%) early elderly (65-74 years) and 410 (27%) late elderly patients (>=75 years). Late elderly subjects were less likely to have their virus genotyped, their viral load assessed or a histological evaluation of liver disease. Overall, 30% of patients had advanced liver disease whose prevalence increased with increasing age. In both age groups, about 40% of patients had normal transaminase levels. Excluding patients with past infection, 51% had not received any antiviral treatment and only 25% were treated after the age of 65. Late elderly patients, women and patients with advanced liver diseases had been less frequently treated. The main reason for exclusion from treatment was age followed by the presence of comorbid conditions. Conclusions: Elderly hepatitis C virus patients referred to Italian specialty clinics have advanced and underestimated liver disease. Nevertheless, they are progressively understudied in parallel with increasing age. © 2012 Editrice Gastroenterologica Italiana S.r.l.

Published
2012
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2. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, Rizzetto, Mario, Mascolo, M. C., Cursaro, C., Scuteri, A., Crespi, C., Gianstefani, A., Ranieri, J., Monti, M., Corti, G., Blanc, P. L., Baragli, F., Bellentani, S., Gasbarrini, A., Pompili, M., Mecenate, F., Picardi, A., Vespasiani, U., Nosotti, Null, Null, A. Picardi, Ricci, G. L., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A. L., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Borghi, A., Sardini, C., Raimondo, G., Scribano, L., Martines, D., Svegliati Baroni, G., Faraci, G., Schi anchi, S., Fornaciari, G., Massari, M., Fabris, P., Bertin, T., Salvagnini, M., Madonia, S., Calì, A., Civitavecchia, G., Pirisi, M., Smirne, C., Andreoletti, M., Morisco, F., Caporaso, N., Gentile, I., Brancaccio, G., Gaeta, G. B., Liberti, A., Iannece, M. D., Rocco, A., Federico, A., Loguercio, C., Riegler, G., Esposito, P., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M. E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Pasulo, L., Lucà, M. G., Grattagliano, I., Palasciano, G., Romagno, D., Giannelli, G., Napoli, N., Plattella, M. S., Cassano, P., Gobbo, G., Monti, V., Raspanti, A., Cuccorese, Null, Colombo, A. E., Mandelli, G., Spinzi, G. C., Floridia, Null, Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., Stefano, G. De, Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Null, G. Raineri, Grossi, P. A., Caputo, S., Cassola, G., Feasi, M., Biagio, A. Di, Nicolini, LAURA AMBRA, Giannini, EDOARDO GIOVANNI, Corbo, M., Foti, G., Kunkar, A., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Framarin, L., Null, M. Berrutti, Ciancio, A., Baiguera, C., Puoti, M., Vento, S., Contini, C., Boccia, S., Casiraghi, M. A., Simone, L., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Null, Messeri, D., Esperti, F. C., Lomonaco, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F. G., Samori, A., Ferretti, E., Marin, R., Campo, N., Testa, R., Rizzo, S., Rosina, F, Tosti, ME, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, AL, Romano, M, Carrara, M, Almasio, PL, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, Rosina, F., Tosti, M. E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, Guglielmo, Andreone, P., Koch, M., Zignego, A. L., Romano, M., Carrara, M., Almasio, P. L., Azzola, E., Nardone, GERARDO ANTONIO PIO, Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., Rizzetto, M., Aifa, Aisf, Simit, Aigo, Sige, Gentile, Ivan, Morisco, Filomena, Et, Al, Floriano Rosina, Maria Elena Tosti, Elisabetta Borghesio, Maria Masocco, Alfonso Mele, Carmine Coppola, Michele Milella, Guglielmo Borgia, Pietro Andreone, Maurizio Koch, Anna Linda Zignego, Mario Romano, Maurizio Carrara, Piero Luigi Almasio, Emilio Azzola, Gerardo Nardone, Antonio Benedetti, Giampiero Carosi, Francesco Mazzotta, Evangelista Sagnelli, and Mario Rizzetto

Subjects
Registrie, Male, Cirrhosis, medicine.disease_cause, Polyethylene Glycol, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Hepatitis Viruses, Hepatitis Viruse, Prospective Studies, Viral, Registries, Chronic, Prospective cohort study, Drug Carrier, Drug Carriers, Settore MED/12 - Gastroenterologia, Medicine (all), Recombinant Protein, Middle Aged, Hepatitis C, Recombinant Proteins, Treatment Outcome, Italy, Combination, RNA, Viral, Population study, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Hepatitis C virus, Alpha interferon, Ribavirin, Sustained virological response (SVR), Treatment, Antiviral Agents, Follow-Up Studie, Hepatology, Drug Therapy, Internal medicine, medicine, Humans, Antiviral Agent, business.industry, Interferon-alpha, HCV therapy, Hepatitis C, Chronic, medicine.disease, Clinical trial, Prospective Studie, chemistry, Immunology, RNA, Follow-Up Studies, business
Abstract

a b s t r a c t Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in “real world” chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peginterferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and -glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in “real world” clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-totreat than among difficult-to-treat hepatitis C virus genotypes.

Published
2014

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

Author

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., and Benetti, G. P.

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Hepatitis, Viral, Human, Alpha interferon, Poison control, Chronic viral hepatitis, Interferon alfa, Side effects, Gastroenterology, Autoimmune Diseases, Internal medicine, Medicine, Humans, Adverse effect, Child, Aged, Retrospective Studies, Hepatitis, Hepatology, business.industry, Thyroid disease, Mental Disorders, Infant, Newborn, Infant, Middle Aged, medicine.disease, Recombinant Proteins, Surgery, Bone marrow suppression, Child, Preschool, Chronic Disease, Interferon Type I, Female, business, Viral hepatitis, medicine.drug
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 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.

Published
1996

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