Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure

Olga Tronina; Michał Brzdęk; Dorota Zarębska-Michaluk; Beata Lorenc; Justyna Janocha-Litwin; Hanna Berak; Marek Sitko; Dorota Dybowska; Włodzimierz Mazur; Magdalena Tudrujek-Zdunek; Ewa Janczewska; Jakub Klapaczyński; Witold Dobracki; Anna Parfieniuk-Kowerda; Rafał Krygier; Łukasz Socha; Robert Flisiak

doi:10.5114/ceh.2023.133307

eISSN: 2449-8238
ISSN: 2392-1099

Clinical and Experimental Hepatology

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abstract:

Original paper

Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure

Olga Tronina

¹

,

Michał Brzdęk

²

,

Dorota Zarębska-Michaluk

³

,

Beata Lorenc

⁴

,

Justyna Janocha-Litwin

⁵

,

Hanna Berak

⁶

,

Marek Sitko

⁷

,

Dorota Dybowska

⁸

,

Włodzimierz Mazur

⁹

,

Magdalena Tudrujek-Zdunek

¹⁰

,

Ewa Janczewska

¹¹

,

Jakub Klapaczyński

¹²

,

Witold Dobracki

¹³

,

Anna Parfieniuk-Kowerda

¹⁴

,

Rafał Krygier

¹⁵

,

Łukasz Socha

¹⁶

,

Robert Flisiak

¹⁴

Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warsaw, Poland
Collegium Medicum, Jan Kochanowski University, Kielce, Poland
Department of Infectious Diseases and Allergology, Jan Kochanowski University, Kielce, Poland
Pomeranian Center of Infectious Diseases, Medical University Gdańsk, Gdańsk, Poland
Department of Infectious Diseases and Hepatology, Wrocław Medical University, Wrocław, Poland
Outpatient Clinic, Hospital for Infectious Diseases in Warsaw, Warsaw, Poland
Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków, Poland
Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland
Clinical Department of Infectious Diseases, Medical University of Silesia, Chorzów, Poland
Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland
Department of Basic Medical Sciences, School of Public Health in Bytom, Medical University of Silesia, Katowice, Poland
Department of Internal Medicine and Hepatology, The National Institute of Medicine of the Ministry of Interior and Administration, Warsaw, Poland
MED-FIX Medical Center, Wrocław, Poland
Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland
Outpatients Hepatology Department, NZOZ GEMINI, Żychlin, Poland
Department of Infectious Diseases, Hepatology, and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland

Clin Exp HEPATOL 2023; 9, 4: 320-334

DOI: https://doi.org/10.5114/ceh.2023.133307

Online publish date: 2023/12/15

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AMA

Tronina O, Brzdęk M, Zarębska-Michaluk D, et al. Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure. Clinical and Experimental Hepatology. 2023;9(4):320-334. doi:10.5114/ceh.2023.133307.

APA

Tronina, O., Brzdęk, M., Zarębska-Michaluk, D., Lorenc, B., Janocha-Litwin, J.,  & Berak, H. et al. (2023). Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure. Clinical and Experimental Hepatology, 9(4), 320-334. https://doi.org/10.5114/ceh.2023.133307

Chicago

Tronina, Olga, Michał Brzdęk, Dorota Zarębska-Michaluk, Beata Lorenc, Justyna Janocha-Litwin, Hanna Berak,  and Marek Sitko et al. 2023. "Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure". Clinical and Experimental Hepatology 9 (4): 320-334. doi:10.5114/ceh.2023.133307.

Harvard

Tronina, O., Brzdęk, M., Zarębska-Michaluk, D., Lorenc, B., Janocha-Litwin, J., Berak, H., Sitko, M., Dybowska, D., Mazur, W., Tudrujek-Zdunek, M., Janczewska, E., Klapaczyński, J., Dobracki, W., Parfieniuk-Kowerda, A., Krygier, R., Socha, Ł.,  and Flisiak, R. (2023). Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure. Clinical and Experimental Hepatology, 9(4), pp.320-334. https://doi.org/10.5114/ceh.2023.133307

MLA

Tronina, Olga et al. "Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure." Clinical and Experimental Hepatology, vol. 9, no. 4, 2023, pp. 320-334. doi:10.5114/ceh.2023.133307.

Vancouver

Tronina O, Brzdęk M, Zarębska-Michaluk D, Lorenc B, Janocha-Litwin J, Berak H et al. Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure. Clinical and Experimental Hepatology. 2023;9(4):320-334. doi:10.5114/ceh.2023.133307.

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Aim of the study:
The aim is to summarize the effectiveness and safety of genotype-specific and pangenotypic hepatitis C virus (HCV) treatments in patients with renal failure.

Material and methods:
In the EpiTer-2 database, which includes data from 22 hepatology centers in Poland, 593 patients with HCV infection and kidney failure were identified. According to KDIGO 2022, they fulfilled the criteria of chronic kidney disease. Patients were divided into two groups: treated with genotype-specific regimens (n = 428) and pangenotypic options (n = 165), in relation to the stage of kidney disease determined using the glomerular filtration rate (GFR) (Cockcroft and Gault equation). Two separate groups were created for hemodialyzed patients (n = 134) and patients after kidney transplantation (n = 89).

Results:
In a total of 593 patients, 78.7% were treatment-naïve and 23.9% had liver cirrhosis, in 27.5% of cases decompensated. In both groups, the dominant genotype was GT1b. Among patients treated with genotype-specific regimens, LDV/SOF ± RBV, OBV/PTV/r + DSV ± RBV, and GZR/EBR ± RBV treatments were given to 31.5%, 31.5%, and 34.8% of patients respectively. In pangenotypic regimens, GLE/PIB was chosen in 50.3%. Ninety-six percent and 98.8% of patients in the genotype-specific regimen and 88.5% and 94.8% in the pangenotypic regimen achieved a sustained virologic response at 12 weeks (SVR12) in the intention-to-treat and per protocol population respectively. Liver cirrhosis was identified as a risk factor for virological failure. During the study, 14 patients died, 7 in each of the two groups, none related to the antiviral treatment.

Conclusions:
Both types of treatment regimens are equally effective and safe in patients with renal failure. The stage of renal failure or transplant does not influence the antiviral response.

keywords:

Real-world effectiveness of genotype-specific and pangenotypic direct-acting antivirals in HCV-infected patients with renal failure

chronic hepatitis C, renal failure, sustained virologic response, direct-acting antivirals, pangenotypic