Effectiveness and Safety of Pangenotypic Regimens in the Most Difficult to Treat Population of Genotype 3 HCV Infected Cirrhotics
Dorota Zarębska‐Michaluk, Jerzy Jaroszewicz, Anna Parfieniuk‐Kowerda, Ewa Janczewska, Dorota Dybowska, Małgorzata Pawłowska, Waldemar Halota, Włodzimierz Mazur, Beata Lorenc, Justyna Janocha‐Litwin, Krzysztof Simon, Anna Piekarska, Hanna Berak, Jakub Klapaczyński, Piotr M. Stępień, Barbara Sobala‐Szczygieł, Jolanta Citko, Łukasz Socha, Magdalena Tudrujek‐Zdunek, Krzysztof Tomasiewicz, Marek Sitko, Beata Dobracka, Rafał Krygier, Jolanta Białkowska, Łukasz Laurans, Robert Flisiak
Abstract
There is still limited data available from real-world experience studies on the pangenotypic regimens in patients with genotype (GT) 3 hepatitis C virus (HCV) infection and liver cirrhosis. The current study aimed to evaluate the efficacy and safety of pangenotypic regimens in this difficult-to-treat population. A total of 236 patients with mean age 52.3 ± 11.3 years and male predominance (72%) selected from EpiTer-2 database were included in the analysis; 72% of them were treatment-naïve. The majority of patients (55%) received the combination of sofosbuvir/velpatasvir (SOF/VEL), 71 without and 58 with ribavirin (RBV), whereas the remaining 107 individuals were assigned to glecaprevir/pibrentasvir (GLE/PIB). The effectiveness of the treatment following GLE/PIB and SOF/VEL regimens (96% and 93%) was higher compared to SOF/VEL + RBV option (79%). The univariate analysis demonstrated the significantly lower sustained virologic response in males, in patients with baseline HCV RNA ≥ 1,000,000 IU/mL, and among those who failed previous DAA-based therapy. The multivariate logistic regression analysis recognized only the male gender and presence of ascites at baseline as the independent factors of non-response to treatment. It should be emphasized that despite the availability of pangenotypic, strong therapeutic options, GT3 infected patients with cirrhosis still remain difficult-to-treat, especially those with hepatic impairment and DAA-experienced.