Effectiveness and Safety of Pangenotypic Regimens in the Most Difficult to Treat Population of Genotype 3 HCV Infected Cirrhotics.

Krzysztof Tomasiewicz,Beata Lorenc,Justyna Janocha-Litwin,Dorota Zarębska-Michaluk,Beata Dobracka,Ewa Janczewska,Anna Piekarska,Barbara Sobala-Szczygieł,Małgorzata Pawłowska,Rafał Krygier,Anna Parfieniuk‐Kowerda ,Jerzy Jaroszewicz,Jolanta Białkowska-Warzecha,Łukasz Laurans,Waldemar Halota,Piotr Stępień,Robert Flisiak,Magdalena Tudrujek-Zdunek,Włodzimierz Mazur,Łukasz Socha,Marek Sitko,Dorota Dybowska,Jolanta Citko,Hanna Berak,Jakub Klapaczyński,Krzysztof Simon

doi:10.3390/jcm10153280

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.

Highlights

Chronic infection with the hepatitis C virus (HCV) seems to be one of the significant health problems worldwide
No significant differences in demographic variables, as well as rates of comorbidities and concomitant medications, were observed between patients treated with two pangenotypic regimens (Table 1)
After more than four years elapsed since the registration of the highly potent pangenotypic regimens, the published data from real-world experience (RWE) studies on the use of these medications in GT3 infected patients with liver cirrhosis are still limited, and most of them included a small number of patients

Summary

Introduction

Chronic infection with the hepatitis C virus (HCV) seems to be one of the significant health problems worldwide. The development of liver fibrosis leading to cirrhosis occurs in nearly 20% of patients, and, on average, two decades of HCV infection are needed for this [2]. The rate of progression of fibrosis varies between different patients and depends on both viral and host predictors [2]. The age of infection over 40 years, coinfection with hepatitis B virus (HBV) and human immunodeficiency virus (HIV), obesity, alcohol abuse are listed among variables related to the infected person, whereas the most important viral predictor for the accelerated fibrosis is genotype (GT) 3 HCV, which is second in frequency worldwide accounting for 25–30% all HCV cases [3,4,5,6]. In the era of interferon (IFN) based therapy, patients with liver cirrhosis had limited access to antiviral treatment due to safety issues and low effectiveness [7]

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Conclusion