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

Antonio Ascione; Massimo De Luca; Mario Melazzini; Simona Montilla; Maria Paola Trotta; Salvatore Petta; Massimo Puoti; Vincenzo Sangiovanni; Vincenzo Messina; Savino Bruno; Antonio Izzi; Erica Villa; Alessio Aghemo; Anna Linda Zignego; Alessandra Orlandini; Luca Fontanella; Antonio Gasbarrini; 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; Michele Barone; 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; Roberto Cauda; 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; Andrea De Luca; Chiara Dentone; Antonio Di Biagio; Alfredo Di Leo; Giovanni Di Perri; Marco Di Stefano; Giampiero D’Offizi; Francesca Donato; Emanuele Durante; Elke Erne; Stefano Fagiuoli; 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; Antonio Grieco; 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; Luca Miele; 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; Gian Ludovico Rapaccini; Maria Rendina; Giuliano Rizzardini; Mario Rizzetto; Salvatore Rizzo; Dante Romagnoli; Antonietta Romano; Cristina Rossi; 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; Maria Rosaria Vinci; Vincenzo Vullo; Teresa Zolfino; Massimo Zuin

doi: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

Antonio Ascione, Massimo De Luca, Mario Melazzini, Simona Montilla, Maria Paola Trotta, Salvatore Petta, Massimo Puoti, Vincenzo Sangiovanni, Vincenzo Messina, Savino Bruno, Antonio Izzi, Erica Villa, Alessio Aghemo, Anna Linda Zignego, Alessandra Orlandini, Luca Fontanella, Antonio Gasbarrini, Marco Marzioni, Edoardo G. Giannini, Antonio CraxìGiuseppe Abbati, Alfredo Alberti, Pietro Andreone, Massimo Andreoni, Paolo Angeli, Mario Angelico, Gioacchino Angarano, Debora Angrisani, Andrea Antinori, Cinzia Antonini, Ivo Avancini, Michele Barone, 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, Roberto Cauda, 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, Andrea De Luca, Chiara Dentone, Antonio Di Biagio, Alfredo Di Leo, Giovanni Di Perri, Marco Di Stefano, Giampiero D’Offizi, Francesca Donato, Emanuele Durante, Elke Erne, Stefano Fagiuoli, 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, Antonio Grieco, 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, Luca Miele, 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, Gian Ludovico Rapaccini, Maria Rendina, Giuliano Rizzardini, Mario Rizzetto, Salvatore Rizzo, Dante Romagnoli, Antonietta Romano, Cristina Rossi, 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, Maria Rosaria Vinci, Vincenzo Vullo, Teresa Zolfino, Massimo Zuin

Risultato della ricerca: Contributo in rivista › Articolo 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 originale	English
pagine (da-a)	607-615
Numero di pagine	9
Rivista	Infection
Volume	46
DOI	https://doi.org/10.1007/s15010-018-1157-x
Stato di pubblicazione	Pubblicato - 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

OSS delle Nazioni Unite

Questo processo contribuisce al raggiungimento dei seguenti obiettivi di sviluppo sostenibile

Accesso al documento

10.1007/s15010-018-1157-x

Altri file e collegamenti

Link a IRIS PubliCatt

Cita questo

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., ... Zuin, M. (2018). Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis. Infection, 46, 607-615. https://doi.org/10.1007/s15010-018-1157-x

@article{dba379977bc84f9996d705ccdcf6e6c3,

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

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.",

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, 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",

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

year = "2018",

doi = "10.1007/s15010-018-1157-x",

language = "English",

volume = "46",

pages = "607--615",

journal = "Infection",

issn = "0300-8126",

publisher = "Urban und Vogel",

}

Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, MP, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, AL, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, EG, Craxì, 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, FC, 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, ADA, Monache, MD, 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, GB, 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, CL, Madonna, S, Magnani, S, Maida, I, Marignani, M, Marrone, A, Marsetti, F, Martini, S, Masarone, M, Maserati, R, Mastroianni, CM, 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, MR, Parruti, G, Pasquazzi, C, Pasulo, L, Perno, CF, Persico, M, Piai, G, Picciotto, A, Pigozzi, GM, Piovesan, S, Piras, MC, Pirisi, M, Piscaglia, AM, Ponti, L, Potenza, D, Pravadelli, C, Quartini, M, Quirino, T, Raimondo, G, Rapaccini, GL, Rendina, M, Rizzardini, G, Rizzetto, M, Rizzo, S, Romagnoli, D, Romano, A, Rossi, C, Rumi, MG, Russello, M, Russo, FP, Russo, ML, Sansonno, DE, Santantonio, TA, Saracco, G, Schimizzi, AM, 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, UV, Vinci, M, Vinci, MR, Vullo, V, Zolfino, T & Zuin, M 2018, 'Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis', Infection, vol. 46, pagg. 607-615. https://doi.org/10.1007/s15010-018-1157-x

TY - JOUR

T1 - Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

AU - Ascione, Antonio

AU - De Luca, Massimo

AU - Melazzini, Mario

AU - Montilla, Simona

AU - Trotta, Maria Paola

AU - Petta, Salvatore

AU - Puoti, Massimo

AU - Sangiovanni, Vincenzo

AU - Messina, Vincenzo

AU - Bruno, Savino

AU - Izzi, Antonio

AU - Villa, Erica

AU - Aghemo, Alessio

AU - Zignego, Anna Linda

AU - Orlandini, Alessandra

AU - Fontanella, Luca

AU - Gasbarrini, Antonio

AU - Marzioni, Marco

AU - Giannini, Edoardo G.

AU - Craxì, Antonio

AU - Abbati, Giuseppe

AU - Alberti, Alfredo

AU - Andreone, Pietro

AU - Andreoni, Massimo

AU - Angeli, Paolo

AU - Angelico, Mario

AU - Angarano, Gioacchino

AU - Angrisani, Debora

AU - Antinori, Andrea

AU - Antonini, Cinzia

AU - Avancini, Ivo

AU - Barone, Michele

AU - Bruno, Raffaele

AU - Benedetti, Antonio

AU - Bernabucci, Veronica

AU - Blanc, Pier

AU - Boarini, Chiara

AU - Boffa, Nicola

AU - Boglione, Lucio

AU - Borghi, Vanni

AU - Borgia, Guglielmo

AU - Brancaccio, Giuseppina

AU - Brunetto, Maurizia

AU - Cacciola, Irene

AU - Calabrese, Paolo

AU - Calvaruso, Vincenza

AU - Campagnolo, Davide

AU - Canovari, Benedetta

AU - Caporaso, Nicola

AU - Capra, Franco

AU - Carolo, Giada

AU - Cassola, Giovanni

AU - Castelli, Francesco

AU - Cauda, Roberto

AU - Silberstein, Francesca Ceccherini

AU - Cecere, Roberto

AU - Chessa, Luchino

AU - Chiodera, Alessandro

AU - Chirianni, Antonio

AU - Ciancio, Alessia

AU - Cima, Serena

AU - Coco, Barbara

AU - Colombo, Massimo

AU - Coppola, Nicola

AU - Corti, Giampaolo

AU - Cosco, Lucio

AU - Corradori, Silvia

AU - Cozzolongo, Raffaele

AU - Cristaudo, Antonio

AU - Danieli, Elena

AU - Monforte, Antonella D’Arminio

AU - Monache, Marco Delle

AU - Del Poggio, Paolo

AU - De Luca, Andrea

AU - Dentone, Chiara

AU - Di Biagio, Antonio

AU - Di Leo, Alfredo

AU - Di Perri, Giovanni

AU - Di Stefano, Marco

AU - D’Offizi, Giampiero

AU - Donato, Francesca

AU - Durante, Emanuele

AU - Erne, Elke

AU - Fagiuoli, Stefano

AU - Falasca, Katia

AU - Federico, Alessandro

AU - Felder, Martina

AU - Ferrari, Carlo

AU - Gaeta, Giovanni Battista

AU - Ganga, Roberto

AU - Gatti, Pietro

AU - Giacomet, Vania

AU - Giacometti, Andrea

AU - Gianstefani, Alice

AU - Giordani, Maria

AU - Giorgini, Alessia

AU - Grieco, Antonio

AU - Guerra, Michele

AU - Gulminetti, Roberto

AU - Ieluzzi, Donatella

AU - Imparato, Michele

AU - Iodice, Valentina

AU - La Monica, Silvia

AU - Lazzarin, Adriano

AU - Lenzi, Marco

AU - Levrero, Massimo

AU - Lichtner, Myriam

AU - Lionetti, Raffaella

AU - Guercio, Carmela Lo

AU - Madonna, Salvatore

AU - Magnani, Silvia

AU - Maida, Ivana

AU - Marignani, Massimo

AU - Marrone, Aldo

AU - Marsetti, Fabio

AU - Martini, Silvia

AU - Masarone, Mario

AU - Maserati, Renato

AU - Mastroianni, Claudio Maria

AU - Memoli, Massimo

AU - Menzaghi, Barbara

AU - Merli, Manuela

AU - Miele, Luca

AU - Milella, Michele

AU - Mondelli, Mario

AU - Montalbano, Marzia

AU - Monti, Monica

AU - Morelli, Olivia

AU - Morisco, Filomena

AU - Nardone, Gaetano

AU - Novara, Sergio

AU - Onnelli, Giovanna

AU - Onofrio, Mirella

AU - Paganin, Simona

AU - Pani, Luca

AU - Parisi, Maria Rita

AU - Parruti, Giustino

AU - Pasquazzi, Caterina

AU - Pasulo, Luisa

AU - Perno, Carlo Federico

AU - Persico, Marcello

AU - Piai, Guido

AU - Picciotto, Antonino

AU - Pigozzi, Grazielle Marie

AU - Piovesan, Sara

AU - Piras, Maria Chiara

AU - Pirisi, Massimo

AU - Piscaglia, Anna Maria

AU - Ponti, Laura

AU - Potenza, Domenico

AU - Pravadelli, Cecilia

AU - Quartini, Mariano

AU - Quirino, Tiziana

AU - Raimondo, Giovanni

AU - Rapaccini, Gian Ludovico

AU - Rendina, Maria

AU - Rizzardini, Giuliano

AU - Rizzetto, Mario

AU - Rizzo, Salvatore

AU - Romagnoli, Dante

AU - Romano, Antonietta

AU - Rossi, Cristina

AU - Rumi, Maria Grazia

AU - Russello, Maurizio

AU - Russo, Francesca Paolo

AU - Russo, Maria Luisa

AU - Sansonno, Domenico Ettore

AU - Santantonio, Teresa Antonia

AU - Saracco, Giorgio

AU - Schimizzi, Anna Maria

AU - Serviddio, Gaetano

AU - Simeone, Filomena

AU - Solinas, Attilio

AU - Soria, Alessandro

AU - Tabone, Marco

AU - Taliani, Gloria

AU - Tarantino, Giuseppe

AU - Tarquini, Pierluigi

AU - Tavio, Marcello

AU - Termite, Antonio

AU - Teti, Elisabetta

AU - Toniutto, Pierluigi

AU - Torti, Carlo

AU - Tundi, Paolo

AU - Vecchiet, Giacomo

AU - Verucchi, Gabriella

AU - Gentilucci, Umberto Vespasiani

AU - Vinci, Maria

AU - Vinci, Maria Rosaria

AU - Vullo, Vincenzo

AU - Zolfino, Teresa

AU - Zuin, Massimo

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Anilides

KW - Antiviral Agents

KW - Biomarkers

KW - Carbamates

KW - Cirrhosis

KW - Dasabuvir

KW - Drug Therapy, Combination

KW - Elderly

KW - Female

KW - Genotype

KW - Hepacivirus

KW - Hepatitis C, Chronic

KW - Humans

KW - Infectious Diseases

KW - Liver Cirrhosis

KW - Macrocyclic Compounds

KW - Male

KW - Microbiology (medical)

KW - Ombitasvir

KW - Paritaprevir

KW - Ribavirin

KW - Ritonavir

KW - Sulfonamides

KW - Treatment Outcome

KW - Uracil

KW - Aged

KW - Aged, 80 and over

KW - Anilides

KW - Antiviral Agents

KW - Biomarkers

KW - Carbamates

KW - Cirrhosis

KW - Dasabuvir

KW - Drug Therapy, Combination

KW - Elderly

KW - Female

KW - Genotype

KW - Hepacivirus

KW - Hepatitis C, Chronic

KW - Humans

KW - Infectious Diseases

KW - Liver Cirrhosis

KW - Macrocyclic Compounds

KW - Male

KW - Microbiology (medical)

KW - Ombitasvir

KW - Paritaprevir

KW - Ribavirin

KW - Ritonavir

KW - Sulfonamides

KW - Treatment Outcome

KW - Uracil

UR - http://hdl.handle.net/10807/134096

U2 - 10.1007/s15010-018-1157-x

DO - 10.1007/s15010-018-1157-x

M3 - Article

SN - 0300-8126

VL - 46

SP - 607

EP - 615

JO - Infection

JF - Infection

ER -

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

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