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 / Ascione A.; De Luca M.; Melazzini M.; Montilla S.; Trotta M.P.; Petta S.; Puoti M.; Sangiovanni V.; Messina V.; Bruno S.; Izzi A.; Villa E.; Aghemo A.; Zignego A.L.; Orlandini A.; Fontanella L.; Gasbarrini A.; Marzioni M.; Giannini E.G.; Craxi A.; Abbati G.; Alberti A.; Andreone P.; Andreoni M.; Angeli P.; Angelico M.; Angarano G.; Angrisani D.; Antinori A.; Antonini C.; Avancini I.; Barone M.; Bruno R.; Benedetti A.; Bernabucci V.; Blanc P.; Boarini C.; Boffa N.; Boglione L.; Borghi V.; Borgia G.; Brancaccio G.; Brunetto M.; Cacciola I.; Calabrese P.; Calvaruso V.; Campagnolo D.; Canovari B.; Caporaso N.; Capra F.; Carolo G.; Cassola G.; Castelli F.; Cauda R.; Silberstein F.C.; Cecere R.; Chessa L.; Chiodera A.; Chirianni A.; Ciancio A.; Cima S.; Coco B.; Colombo M.; Coppola N.; Corti G.; Cosco L.; Corradori S.; Cozzolongo R.; Cristaudo A.; Danieli E.; Monforte A.D.A.; Monache M.; Del Poggio P.; de Luca A.; Dentone C.; Di Biagio A.; Di Leo A.; Di Perri G.; Di Stefano M.; D'Offizi G.; Donato F.; Durante E.; Erne E.; Fagiuoli S.; Falasca K.; Federico A.; Felder M.; Ferrari C.; Gaeta G.B.; Ganga R.; Gatti P.; Giacomet V.; Giacometti A.; Gianstefani A.; Giordani M.; Giorgini A.; Grieco A.; Guerra M.; Gulminetti R.; Ieluzzi D.; Imparato M.; Iodice V.; La Monica S.; Lazzarin A.; Lenzi M.; Levrero M.; Lichtner M.; Lionetti R.; Guercio C.L.; Madonna S.; Magnani S.; Maida I.; Marignani M.; Marrone A.; Marsetti F.; Martini S.; Masarone M.; Maserati R.; Mastroianni C.M.; Memoli M.; Menzaghi B.; Merli M.; Miele L.; Milella M.; Mondelli M.; Montalbano M.; Monti M.; Morelli O.; Morisco F.; Nardone G.; Novara S.; Onnelli G.; Onofrio M.; Paganin S.; Pani L.; Parisi M.R.; Parruti G.; Pasquazzi C.; Pasulo L.; Perno C.F.; Persico M.; Piai G.; Picciotto A.; Pigozzi G.M.; Piovesan S.; Piras M.C.; Pirisi M.; Piscaglia A.M.; Ponti L.; Potenza D.; Pravadelli C.; Quartini M.; Quirino T.; Raimondo G.; Rapaccini G.L.; Rendina M.; Rizzardini G.; Rizzetto M.; Rizzo S.; Romagnoli D.; Romano A.; Rossi C.; Rumi M.G.; Russello M.; Russo F.P.; Russo M.L.; Sansonno D.E.; Santantonio T.A.; Saracco G.; Schimizzi A.M.; Serviddio G.; Simeone F.; Solinas A.; Soria A.; Tabone M.; Taliani G.; Tarantino G.; Tarquini P.; Tavio M.; Termite A.; Teti E.; Toniutto P.; Torti C.; Tundi P.; Vecchiet G.; Verucchi G.; Gentilucci U.V.; Vinci M.; Vullo V.; Zolfino T.; Zuin M.. - In: INFECTION. - ISSN 0300-8126. - STAMPA. - 46:(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
Messina V.;Zignego A. L.;Abbati G.;Andreoni M.;Borghi V.;Brunetto M.;Caporaso N.;Corti G.;Cosco L.;Danieli E.;Di Leo A.;Donato F.;Giacometti A.;Giordani M.;Giorgini A.;Grieco A.;Imparato M.;Lionetti R.;Magnani S.;Maida I.;Memoli M.;Monti M.;Morelli O.;Nardone G.;Pani L.;Ponti L.;Raimondo G.;Romagnoli D.;Serviddio G.;Simeone F.;Solinas A.;Taliani G.;
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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