Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study

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

Risultato della ricerca: Contributo in rivistaArticolo in rivista

15 Citazioni (Scopus)

Abstract

Background We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. Methods In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once daily and dasabuvir (250 mg) twice daily for 12 weeks (patients with HCV genotype 1b infection) or 24 weeks (patients with HCV genotype 1a infection). Patients with HCV genotype 4 infection were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once per day for 24 weeks. All patients were given weight-based ribavirin. The primary efficacy endpoint was sustained virological response at week 12 after the end of treatment (SVR12), analysed by intention-to-treat. Univariate and multivariate logistic regression analyses were used to identify baseline characteristics associated with SVR12. Adverse events were recorded throughout the study. Findings 728 (96%) of 762 patients with cirrhosis who were given ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin therapy for 12 or 24 weeks achieved SVR12. Logistic regression analyses identified that bilirubin concentrations of less than 2 mg/dL were associated with SVR12 (odds ratio [OR] 4·76 [95% CI 1·83–12·3]; p=0·001). 166 (23%) of 734 patients included in safety analyses had an adverse event. 25 (3%) patients discontinued treatment because of adverse events. Asthenia was the most commonly reported adverse event, occurring in 36 (5%) patients. Interpretation Our findings suggest that the safety and effectiveness of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin in patients with HCV genotype 1 or 4 infection and cirrhosis at high risk of decompensation in a real-life setting are similar to those reported in clinical trials. The concordance with clinical trials provides reassurance that the reported efficacy of this treatment in clinical trials will translate to its use in routine clinical practice. Funding Dipartimento Biomedico di Medicina Interna e Specialistica dell'Universita di Palermo.
Lingua originaleEnglish
pagine (da-a)427-434
Numero di pagine8
RivistaTHE LANCET. GASTROENTEROLOGY & HEPATOLOGY
Volume2
DOI
Stato di pubblicazionePubblicato - 2017

Keywords

  • Gastroenterology
  • Hepatology

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