Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Antonio Gasbarrini, Roberto Cauda, Antonio Grieco, Luca Miele, Gian Ludovico Rapaccini, Michele Barone, Andrea De Luca, Stefano Fagiuoli, Cristina Rossi, Maria Rosaria Vinci, Antonio Ascione, Massimo De Luca, Mario Melazzini, Simona Montilla, Maria Paola Trotta, Salvatore Petta, Massimo Puoti, Vincenzo Sangiovanni, Vincenzo Messina, Savino BrunoAntonio Izzi, Erica Villa, Alessio Aghemo, Anna Linda Zignego, Alessandra Orlandini, Luca Fontanella, Marco Marzioni, Edoardo G. Giannini, Antonio Craxì, Giuseppe Abbati, Alfredo Alberti, Pietro Andreone, Massimo Andreoni, Paolo Angeli, Mario Angelico, Gioacchino Angarano, Debora Angrisani, Andrea Antinori, Cinzia Antonini, Ivo Avancini, Raffaele Bruno, Antonio Benedetti, Veronica Bernabucci, Pier Blanc, Chiara Boarini, Nicola Boffa, Lucio Boglione, Vanni Borghi, Guglielmo Borgia, Giuseppina Brancaccio, Maurizia Brunetto, Irene Cacciola, Paolo Calabrese, Vincenza Calvaruso, Davide Campagnolo, Benedetta Canovari, Nicola Caporaso, Franco Capra, Giada Carolo, Giovanni Cassola, Francesco Castelli, Francesca Ceccherini Silberstein, Roberto Cecere, Luchino Chessa, Alessandro Chiodera, Antonio Chirianni, Alessia Ciancio, Serena Cima, Barbara Coco, Massimo Colombo, Nicola Coppola, Giampaolo Corti, Lucio Cosco, Silvia Corradori, Raffaele Cozzolongo, Antonio Cristaudo, Elena Danieli, Antonella D’Arminio Monforte, Marco Delle Monache, Paolo Del Poggio, Chiara Dentone, Antonio Di Biagio, Alfredo Di Leo, Giovanni Di Perri, Marco Di Stefano, Giampiero D’Offizi, Francesca Donato, Emanuele Durante, Elke Erne, Katia Falasca, Alessandro Federico, Martina Felder, Carlo Ferrari, Giovanni Battista Gaeta, Roberto Ganga, Pietro Gatti, Vania Giacomet, Andrea Giacometti, Alice Gianstefani, Maria Giordani, Alessia Giorgini, Michele Guerra, Roberto Gulminetti, Donatella Ieluzzi, Michele Imparato, Valentina Iodice, Silvia La Monica, Adriano Lazzarin, Marco Lenzi, Massimo Levrero, Myriam Lichtner, Raffaella Lionetti, Carmela Lo Guercio, Salvatore Madonna, Silvia Magnani, Ivana Maida, Massimo Marignani, Aldo Marrone, Fabio Marsetti, Silvia Martini, Mario Masarone, Renato Maserati, Claudio Maria Mastroianni, Massimo Memoli, Barbara Menzaghi, Manuela Merli, Michele Milella, Mario Mondelli, Marzia Montalbano, Monica Monti, Olivia Morelli, Filomena Morisco, Gaetano Nardone, Sergio Novara, Giovanna Onnelli, Mirella Onofrio, Simona Paganin, Luca Pani, Maria Rita Parisi, Giustino Parruti, Caterina Pasquazzi, Luisa Pasulo, Carlo Federico Perno, Marcello Persico, Guido Piai, Antonino Picciotto, Grazielle Marie Pigozzi, Sara Piovesan, Maria Chiara Piras, Massimo Pirisi, Anna Maria Piscaglia, Laura Ponti, Domenico Potenza, Cecilia Pravadelli, Mariano Quartini, Tiziana Quirino, Giovanni Raimondo, Maria Rendina, Giuliano Rizzardini, Mario Rizzetto, Salvatore Rizzo, Dante Romagnoli, Antonietta Romano, Maria Grazia Rumi, Maurizio Russello, Francesca Paolo Russo, Maria Luisa Russo, Domenico Ettore Sansonno, Teresa Antonia Santantonio, Giorgio Saracco, Anna Maria Schimizzi, Gaetano Serviddio, Filomena Simeone, Attilio Solinas, Alessandro Soria, Marco Tabone, Gloria Taliani, Giuseppe Tarantino, Pierluigi Tarquini, Marcello Tavio, Antonio Termite, Elisabetta Teti, Pierluigi Toniutto, Carlo Torti, Paolo Tundi, Giacomo Vecchiet, Gabriella Verucchi, Umberto Vespasiani Gentilucci, Maria Vinci, Vincenzo Vullo, Teresa Zolfino, Massimo Zuin

Risultato della ricerca: Contributo in rivistaArticolo in rivista

6 Citazioni (Scopus)

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.
Lingua originaleEnglish
pagine (da-a)607-615
Numero di pagine9
RivistaInfection
Volume46
DOI
Stato di pubblicazionePubblicato - 2018

Keywords

  • Aged
  • Aged, 80 and over
  • Anilides
  • Antiviral Agents
  • Biomarkers
  • Carbamates
  • Cirrhosis
  • Dasabuvir
  • Drug Therapy, Combination
  • Elderly
  • Female
  • Genotype
  • Hepacivirus
  • Hepatitis C, Chronic
  • Humans
  • Infectious Diseases
  • Liver Cirrhosis
  • Macrocyclic Compounds
  • Male
  • Microbiology (medical)
  • Ombitasvir
  • Paritaprevir
  • Ribavirin
  • Ritonavir
  • Sulfonamides
  • Treatment Outcome
  • Uracil

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