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Real‐world effectiveness and safety of direct‐acting antivirals in patients with cirrhosis and history of hepatic decompensation: Epi‐Ter2 Study

2021; Wiley; Volume: 41; Issue: 8 Linguagem: Inglês

10.1111/liv.14858

1478-3231

Aleksandra Berkan‐Kawińska, Anna Piekarska, Ewa Janczewska, Beata Lorenc, Magdalena Tudrujek‐Zdunek, Krzysztof Tomasiewicz, Hanna Berak, Andrzej Horban, Dorota Zarębska‐Michaluk, Paweł Pabjan, Iwona Buczyńska, Monika Pazgan‐Simon, Dorota Dybowska, Waldemar Halota, Małgorzata Pawłowska, Jakub Klapaczyński, Włodzimierz Mazur, Agnieszka Czauż‐Andrzejuk, Łukasz Socha, Łukasz Laurans, Aleksander Garlicki, Marek Sitko, Jerzy Jaroszewicz, Jolanta Citko, Beata Dobracka, Rafał Krygier, Jolanta Białkowska, Olga Tronina, Teresa Belica‐Wdowik, Barbara Baka‐Ćwierz, Robert Flisiak,

Liver Disease and Transplantation

The aim of this study was to assess the real-life effectiveness and safety of direct acting antivirals (DAAs) in patients with cirrhosis and history of hepatic decompensation compared to those with compensated cirrhosis.Data of patients treated with DAAs and included in the EpiTer-2 database (N = 10 152) were collected retrospectively. The primary endpoint was sustained viral response (SVR) at 12 weeks posttreatment. Patients were also evaluated in terms of liver-related adverse events and treatment modification/discontinuation.The overall SVR rate was 91.4% in the intent to treat (ITT) analysis and 95.2% in the per-protocol (PP) analysis (P < .001). Patients with decompensated cirrhosis had lower SVR rates compared to those with compensated cirrhosis in ITT analysis (86.4% vs 92.0%, P < .001), while not in PP analysis (92.9% vs 95.5%, P > .05). Adverse events (AE) occurred 45.6% and 29.3% of patients with decompensated and compensated cirrhosis (P < .001). Patients with decompensated cirrhosis were at higher risk of death (5.4% vs 0.9%; P < .0001) or liver decompensation (21.5% vs 1.3%; P < .0001). Treatment with protease inhibitors was not associated with hepatic decompensation (P = .3). Only 82.6% of patients with decompensated cirrhosis completed DAA treatment (vs 92.8% in compensated cirrhotics; P < .0001).Despite higher frequency of AE and treatment modifications, once completed, DAAs yield comparable results for patients with decompensated and compensated cirrhosis. High rate of serious adverse events in patients with advanced liver disease treated with PI may not be related to the detrimental effect of the medications, but rather to the disease itself.