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

Petta, Salvatore; Marzioni, Marco; Russo, Pierluigi; Aghemo, Alessio; Alberti, Alfredo; Ascione, Antonio; Antinori, Andrea; Bruno, Raffaele; Bruno, Savino; Chirianni, Antonio; Gaeta, Giovanni Battista; Giannini, Edoardo G.; Merli, Manuela; Messina, Vito; Montilla, Simona; Perno, Carlo Federico; Puoti, Massimo; Raimondo, Giovanni; Rendina, Maria; Ceccherini‐Silberstein, Francesca; Villa, Erica; Zignego, Anna Linda; Pani, Luca; Craxı̀, Antonio; Tabone, M.; Andreoni, Massimo; Teti, Elisabetta; Angélico, M.; Persico, Marcello; Masarone, Mario; Chiodera, Aledssandro; Solinas, Attilio; Monache, M. Delle; Cecere, Roberto; Schimizzi, Anna Maria; Piovesan, Sara; Campagnolo, Davide; Piras, Maria Chiara; Zolfino, T.; Russo, Francesca Paolo; Morelli, Olivia; Sangiovanni, Vincenzo; Onofrio, Mirella; Iodice, V.; Izzi, Antonio; Pirisi, M.; Danieli, Elena; Vinci, M.; Rizzardini, Giuliano; Fagiuoli, Stefano; Pasulo, L.; Monforte, Antonella d’Arminio; Zuin, Massimo; Giorgini, Alessia; Simeone, Filomena; Piali, Guido; Guercio, Carmela Lo; Federico, Alessandro Di; Brancaccio, Giuseppina; Marrone, Aldo; Abbati, Giuseppe; Boarini, Chiara; Borghi, Vanni; Bernabucci, Veronica; Corti, Giampaolo; Monti, Monica; Rizzetto, Mario; Martini, Silvia; Andreone, Pietro; Gianstefani, Alice; Lenzi, Marco; Verucchi, Gabriella; Toniutto, Pierluigi; Borgia, Guglielmo; Caporaso, N.; Morisco, Filomena; Nardone, Gaetano; Angrisani, Debora; Giacometti, Andrea; Benedetti, Antonio; Tarantino, Giuseppe; Marsetti, Fabio; Tavio, Marcello; Novara, Sergio; Santantonio, T.; Serviddio, Gaetano; Brunetto, Maurizia Rossana; Coco, B.; Angarano, Gioacchino; Milella, Michele Stanislaw; Barone, M.; Leo, Alfredo Di; Sansonno, Domenico; Cacciola, Irene; Boffa, Nicola; Saracco, Giorgio Maria; Biagio, Antonio Di; Picciotto, Antonino; Luca, Andrea De; Calvaruso, V.; Corradori, Silvia; Ferrari, Carlo; Orlandini, A.; Maida, Ivana; Torti, Carlo; Chessa, Luchino; Felder, Martina; Gentilucci, Umberto Vespasiani; Angeli, Paolo; Romano, A.; Rapaccini, Gian Ludovico; Miele, Luca; Cima, Serena; Russo, María Luisa; Cozzolongo, Raffaele; Onnelli, Giovanna; D’Offizi, Giampiero; Lionetti, Raffaella; Montalbano, Marzia; Guerra, M.; Perri, Giovanni Di; Boglione, Lucio; Capra, Franco; Carolo, Giada; Ieluzzi, Donatella; Antonini, Cinzia; Termite, Antonio Patrizio; Madonia, Salvatore; Tarquini, Pierluigi; Parruti, Giustino; Vecchiet, Giacomo; Falasca, Katia; Menzaghi, Barbara; Quirino, Tiziana; Dentone, Chiara; Piscaglia, Anna Maria; Rossi, Cristina; Giordani, Maria Teresa; Fontanella, Luca; Cassola, Giovanni; Russello, Maurizio; Cristaudo, Antonio; Giacomet, Vania; Colombo, Massimo; Donato, F.; Durante, Emanuele; Cosco, Lucio; Marignani, Massimo; Quartini, Mariano; Memoli, Massimo; Ganga, R.; Ponti, Laura; Soria, Alessandro; Rumi, Maria Grazia; Gulminetti, Roberto; Maserati, Renato; Mondelli, Mario U.; Lazzarin, Adriano; Parisi, Maria Rita; Canovari, Benedetta; Avancini, Ivo; Pravadelli, Cecilia; Blanc, Pier Luigi; Pasquazzi, C.; Mastroianni, Claudio Maria; Lichtner, Myriam; Distefano, Marco; Magnani, Silvia; Paganin, S.; Erne, Elke; Gatti, Pietro; Tundi, Paolo; Calabrese, P.; Gasbarrini, Antonio; Grieco, Antonio; Coppola, Nicola; Poggio, P. Del; Levrero, Massimo; Talliani, Gloria; Vullo, Vincenzo; Cauda, Roberto; Monica, Silvia La; Potenza, Domenico; Rizzo, Salvatore; Castelli, Francesco; Pigozzi, G.; Ciancio, Alessia; Romagnoli, Dante; Barchetti, Federica; Ivanović, Jelena; Longo, Olimpia; Petraglia, Sandra; Trotta, Maria Paola

doi:10.1016/s2468-1253(17)30048-1

Cited by 18 publications

(24 citation statements)

References 14 publications

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“…Further studies showed comparable SVR rates among patients with advanced liver disease, as well as improvement in disease severity (namely improvement in MELD and CHILD scores). Such results were found early after the end of the treatment (5,6).…”

mentioning

confidence: 58%

Direct acting antiviral agents and hepatocellular carcinoma development: don’t take it for granted

Buonomo

Gentile

Borgia

2017

Transl. Gastroenterol. Hepatol.

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mentioning

confidence: 58%

Direct acting antiviral agents and hepatocellular carcinoma development: don’t take it for granted

Buonomo

Gentile

Borgia

2017

Transl. Gastroenterol. Hepatol.

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“…DAA-based therapies are effective and safe and result in an SVR of about 97%. [1][2][3][4][5][6][7][8][9][10][11][12] This means that 3% of treated patients do not achieve an SVR, mostly because of virological relapse, and frequently develop resistance-associated substitutions in the NS5a viral protein and resistance to available regimens. 37 Even if this proportion is small, this still represents a significant absolute number of patients who will fail HCV eradication, considering the large numbers of patients who are or will be treated.…”

Section: Are There Clinical Obstacles To the Elimination Of Hcv?mentioning

confidence: 99%

“…The optimal safety profile and effectiveness of short regimens (8-24 weeks) of direct antiviral agents (DAA) has been confirmed in clinical trials and universally in real-life cohorts. [1][2][3][4][5][6][7][8][9][10][11][12] DAA-based therapies can be administered to patients with HCV infection and a wide spectrum of liver damage from mild disease to de- World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, with the final goal of eliminating viral hepatitis as a major public health threat by 2030. 13 Elimination of a disease involves the reduction in the prevalence of the disease in a regional population to zero, or the reduction in the global prevalence to a negligible amount.…”

Section: Introductionmentioning

confidence: 99%

Is global elimination of HCV realistic?

Calvaruso

Petta

2018

Liver International

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The elimination of hepatitis C virus (HCV) has been made possible through the availability of new antiviral drugs which may now be administered to all patients with HCV infection, even those with decompensated cirrhosis. The goal of the World Health Organization (WHO) is to reduce the incidence of chronic hepatitis infection from the current 6-10 million to 0.9 million cases of chronic infections by 2030, and annual deaths from 1.4 million to fewer than 0.5 million. Achieving these targets will require

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“…DAA therapy has high success rate (more than 90%) and fewer side effects than the interferon-based regimens. [22][23][24][25][26] The current guidelines for coinfected patients with HCV and HBV recommend that when HCV is replicative, the patient should receive the standard treatment for HCV infection. 27,28 A major concern in the treatment of HBV-HCV co-infection is a "flare-up" of hepatitis due to the risk of HBV reactivation during or after HCV clearance that may increase the risk of liver damage.…”

Section: Introductionmentioning

confidence: 99%

Risk of hepatitis B virus reactivation in hepatitis B virus + hepatitis C virus‐co‐infected patients with compensated liver cirrhosis treated with ombitasvir, paritaprevir/r + dasabuvir + ribavirin

Preda

Popescu

Băicuș

et al. 2018

Journal of Viral Hepatitis

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Hepatitis B virus may reactivate in patients with chronic hepatitis C treated with direct-acting antivirals. The aim of this study was to investigate the risk of hepatitis B virus (HBV) reactivation in HBV + hepatitis C virus (HCV)-co-infected patients with compensated liver cirrhosis treated with paritaprevir/ombitasvir/ritonavir, dasabuvir with ribavirin. We reviewed prospectively gathered data from a national cohort of 2070 hepatitis C virus patients with compensated liver cirrhosis who received reimbursed paritaprevir/ombitasvir/r, dasabuvir with ribavirin for 12 weeks from the Romanian National Health Agency during 2015-2016. Twenty-five patients in this cohort were HBs antigen positive (1.2%); 15 untreated with nucleotide analogues agreed to enter the study. These patients were followed up: ALT monthly, serology for HBV and DNA viral load at baseline, EOT and SVR at 12 weeks. Hepatitis B virus (HBV)-co-infected patients were all genotype 1b and 52% females, with a median age of 60 years (51 ÷ 74); 76% were pretreated with peginterferon + ribavirin; 72% were with severe necroinflammatory activity on FibroMax assessment; 40% presented comorbidities; and all were HBe antigen negative. Hepatitis C virus (HCV) SVR response rate was 100%. Hepatitis B virus (HBV)-DNA viral load was undetectable in 7/15 (47%) before therapy, and for the other 8 patients, it varied between below 20 and 867 IU/mL. Five patients (33%) presented virological reactivation (>2 log increase in HBV-DNA levels) during therapy. One patient presented with hepatitis associated with HBV reactivation, and two started anti-HBV therapy with entecavir. Hepatitis B virus (HBV) virological reactivation was present in 33% in our patients. Generally, HBV-DNA elevations were mild (<20 000 IU/mL); however, we report one case of hepatitis associated with HBV reactivation.

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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

Cited by 18 publications

References 14 publications

Direct acting antiviral agents and hepatocellular carcinoma development: don’t take it for granted

Direct acting antiviral agents and hepatocellular carcinoma development: don’t take it for granted

Is global elimination of HCV realistic?

Risk of hepatitis B virus reactivation in hepatitis B virus + hepatitis C virus‐co‐infected patients with compensated liver cirrhosis treated with ombitasvir, paritaprevir/r + dasabuvir + ribavirin

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