The efficacy and tolerability of glecaprevir/pibrentasvir treatment in a real-world chronic hepatitis C patients cohort.

IF 1.2 Q4 GASTROENTEROLOGY & HEPATOLOGY Hepatology Forum Pub Date : 2023-09-20 eCollection Date: 2023-01-01 DOI:10.14744/hf.2023.2023.0001
Serkan Yaras, Mehmet Demir, Sezgin Barutcu, Abdullah Emre Yildirim, Selim Gurel, Enver Ucbilek, Ilkce Akgun Kurtulmus, Meral Akdogan Kayhan, Sezgin Vatansever, Haydar Adanir, Nilay Danis, Serkan Duman, Ilker Turan, Derya Ari, Sukran Kose, Huseyin Alkim, Muhsin Murat Harputluoglu, Feyza Dilber, Murat Akyildiz, Arif Mansur Cosar, Serdar Durak, Goktug Sirin, Ayse Kefeli, Hale Gokcan, Ufuk Avcioglu, Talat Ayyildiz, Orhan Sezgin, Mesut Akarsu, Dinc Dincer, Fatih Guzelbulut, Fulya Gunsar, Ulus Salih Akarca, Ramazan Idilman
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Abstract

Background and aim: The aims of the present study were to evaluate the real-life efficacy and tolerability of glecaprevir (GLE)/pibrentasvir (PIB) in the treatment of patients with chronic hepatitis C (CHC).

Materials and methods: Between May 2019 and May 2022, 686 patients with CHC, treated with GLE/PIB combination from 21 participating centers in Turkiye, were enrolled in the study.

Results: All patients were Caucasian, and their median age was 56 years. At the start of GLE/PIB treatment, the median serum Hepatitis C virus RNA and serum alanine amino transaminase (ALT) levels were 6.74 log10 IU/mL and 47 U/L, respectively. Fifty-three percent of the patients were infected with genotype 1b, followed by genotype 3 (17%). Diabetes was the more common concomitant disease. The sustained virological response (SVR12) was 91.4% with intent-to-treat analysis and 98.5% with per protocol analysis. The SVR12 rates were statistically significant differences between the patients who were i.v. drug users and non-user (88.0% vs. 98.8%, p=0.025). From the baseline to SVR12, the serum ALT levels and Model for End-Stage Liver Disease score were significantly improved (p<0.001 and p=0.014, respectively). No severe adverse effect was observed.

Conclusion: GLE/PIB is an effective and tolerable treatment in patients with CHC.

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格列卡韦/皮布伦他韦治疗实际慢性丙型肝炎患者队列的疗效和耐受性。
背景和目的:本研究的目的是评估格列卡韦(GLE)/皮布伦他韦(PIB)治疗慢性丙型肝炎(CHC)患者的实际疗效和耐受性。材料和方法:2019年5月至2022年5月,来自土耳其21个参与中心的686名CHC患者接受了GLE/PIB联合治疗。结果:所有患者均为高加索人,中位年龄为56岁。在GLE/PIB治疗开始时,血清丙型肝炎病毒RNA和血清丙氨酸氨基转氨酶(ALT)的中位水平分别为6.74log10IU/mL和47U/L。53%的患者感染了基因型1b,其次是基因型3(17%)。糖尿病是更常见的合并疾病。意向治疗分析的持续病毒学应答(SVR12)为91.4%,按方案分析为98.5%。静脉注射吸毒者和非吸毒者的SVR12发生率有统计学意义(88.0%对98.8%,p=0.025)。从基线到SVR12,血清ALT水平和终末期肝病模型评分均有显著改善(p结论:GLE/PIB是CHC患者有效且可耐受的治疗方法。
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