Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.
Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis / A. Ascione, M. De Luca, M. Melazzini, S. Montilla, M.P. Trotta, S. Petta, M. Puoti, V. Sangiovanni, V. Messina, S. Bruno, A. Izzi, E. Villa, A. Aghemo, A.L. Zignego, A. Orlandini, L. Fontanella, A. Gasbarrini, M. Marzioni, E.G. Giannini, A. Craxì, G. Abbati, A. Alberti, P. Andreone, M. Andreoni, P. Angeli, M. Angelico, G. Angarano, D. Angrisani, A. Antinori, C. Antonini, I. Avancini, M. Barone, R. Bruno, A. Benedetti, V. Bernabucci, P. Blanc, C. Boarini, N. Boffa, L. Boglione, V. Borghi, G. Borgia, G. Brancaccio, M. Brunetto, I. Cacciola, P. Calabrese, V. Calvaruso, D. Campagnolo, B. Canovari, N. Caporaso, F. Capra, G. Carolo, G. Cassola, F. Castelli, R. Cauda, F.C. Silberstein, R. Cecere, L. Chessa, A. Chiodera, A. Chirianni, A. Ciancio, S. Cima, B. Coco, M. Colombo, N. Coppola, G. Corti, L. Cosco, S. Corradori, R. Cozzolongo, A. Cristaudo, E. Danieli, A.D. Monforte, M.D. Monache, P. Del Poggio, A. de Luca, C. Dentone, A. Di Biagio, A. Di Leo, G. Di Perri, M. Di Stefano, G. D’Offizi, F. Donato, E. Durante, E. Erne, S. Fagiuoli, K. Falasca, A. Federico, M. Felder, C. Ferrari, G.B. Gaeta, R. Ganga, P. Gatti, V. Giacomet, A. Giacometti, A. Gianstefani, M. Giordani, A. Giorgini, A. Grieco, M. Guerra, R. Gulminetti, D. Ieluzzi, M. Imparato, V. Iodice, S. La Monica, A. Lazzarin, M. Lenzi, M. Levrero, M. Lichtner, R. Lionetti, C.L. Guercio, S. Madonna, S. Magnani, I. Maida, M. Marignani, A. Marrone, F. Marsetti, S. Martini, M. Masarone, R. Maserati, C.M. Mastroianni, M. Memoli, B. Menzaghi, M. Merli, L. Miele, M. Milella, M. Mondelli, M. Montalbano, M. Monti, O. Morelli, F. Morisco, G. Nardone, S. Novara, G. Onnelli, M. Onofrio, S. Paganin, L. Pani, M.R. Parisi, G. Parruti, C. Pasquazzi, L. Pasulo, C.F. Perno, M. Persico, G. Piai, A. Picciotto, G.M. Pigozzi, S. Piovesan, M.C. Piras, M. Pirisi, A.M. Piscaglia, L. Ponti, D. Potenza, C. Pravadelli, M. Quartini, T. Quirino, G. Raimondo, G.L. Rapaccini, M. Rendina, G. Rizzardini, M. Rizzetto, S. Rizzo, D. Romagnoli, A. Romano, C. Rossi, M.G. Rumi, M. Russello, F.P. Russo, M.L. Russo, D.E. Sansonno, T.A. Santantonio, G. Saracco, A.M. Schimizzi, G. Serviddio, F. Simeone, A. Solinas, A. Soria, M. Tabone, G. Taliani, G. Tarantino, P. Tarquini, M. Tavio, A. Termite, E. Teti, P. Toniutto, C. Torti, P. Tundi, G. Vecchiet, G. Verucchi, U.V. Gentilucci, M. Vinci, V. Vullo, T. Zolfino, M. Zuin. - In: INFECTION. - ISSN 0300-8126. - 46:5(2018), pp. 607-615. [10.1007/s15010-018-1157-x]
Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis
A.D. Monforte;V. Giacomet;A. Grieco;C.F. Perno;M.G. Rumi;M. Zuin
2018
Abstract
Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.
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