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

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY Clinical and Experimental Hepatology Pub Date : 2023-12-01 Epub Date: 2023-12-15 DOI:10.5114/ceh.2023.133307
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
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Abstract

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.

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基因型特异性和泛基因型直接作用抗病毒药物对肾功能衰竭的 HCV 感染者的实际疗效。
研究目的目的是总结肾衰竭患者接受基因型特异性和泛基因型丙型肝炎病毒(HCV)治疗的有效性和安全性:在 EpiTer-2 数据库(包括来自波兰 22 个肝病中心的数据)中,确定了 593 名感染 HCV 且肾衰竭的患者。根据 KDIGO 2022,他们符合慢性肾病的标准。根据使用肾小球滤过率(GFR)(Cockcroft 和 Gault 方程)确定的肾病阶段,将患者分为两组:基因型特异性治疗方案组(428 人)和泛基因型治疗方案组(165 人)。血液透析患者(n = 134)和肾移植患者(n = 89)分为两组:在593名患者中,78.7%为治疗无效患者,23.9%为肝硬化患者,其中27.5%为肝硬化失代偿期患者。两组患者的主要基因型均为 GT1b。在接受基因型特异性方案治疗的患者中,分别有31.5%、31.5%和34.8%的患者接受了LDV/SOF ± RBV、OBV/PTV/r + DSV ± RBV和GZR/EBR ± RBV治疗。在泛基因型方案中,50.3% 的患者选择了 GLE/PIB。在意向治疗人群和按方案治疗人群中,分别有96%和98.8%的基因型特异性方案患者和88.5%和94.8%的泛基因型方案患者在12周后获得持续病毒学应答(SVR12)。肝硬化被确定为病毒学失败的风险因素。研究期间,14 名患者死亡,两组各 7 人,均与抗病毒治疗无关:结论:两种治疗方案对肾功能衰竭患者同样有效和安全。肾功能衰竭或移植阶段并不影响抗病毒反应。
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来源期刊
Clinical and Experimental Hepatology
Clinical and Experimental Hepatology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
2.80
自引率
0.00%
发文量
32
期刊介绍: Clinical and Experimental Hepatology – quarterly of the Polish Association for Study of Liver – is a scientific and educational, peer-reviewed journal publishing original and review papers describing clinical and basic investigations in the field of hepatology.
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