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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
Author(s) -
BerkanKawińska Aleksandra,
Piekarska Anna,
Janczewska Ewa,
Lorenc Beata,
TudrujekZdunek Magdalena,
Tomasiewicz Krzysztof,
Berak Hanna,
Horban Andrzej,
ZarębskaMichaluk Dorota,
Pabjan Paweł,
Buczyńska Iwona,
PazganSimon Monika,
Dybowska Dorota,
Halota Waldemar,
Pawłowska Małgorzata,
Klapaczyński Jakub,
Mazur Włodzimierz,
CzaużAndrzejuk Agnieszka,
Socha Łukasz,
Laurans Łukasz,
Garlicki Aleksander,
Sitko Marek,
Jaroszewicz Jerzy,
Citko Jolanta,
Dobracka Beata,
Krygier Rafał,
BiałkowskaWarzecha Jolanta,
Tronina Olga,
BelicaWdowik Teresa,
BakaĆwierz Barbara,
Flisiak Robert
Publication year - 2021
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14858
Subject(s) - decompensation , cirrhosis , medicine , discontinuation , adverse effect , gastroenterology , clinical endpoint , liver disease , randomized controlled trial
Abstract Background and Aims 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. Method 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. Results 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). Conclusion 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.