Abulitifu Yilihamu, Lian Jiangshan, Adilijiang Munire, Liu Lan, Zhao Fengcong, Qian Wen, Zhang Yongping
Department of Infectious Diseases, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, People's Republic of China.
Department of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, People's Republic of China.
Infect Drug Resist. 2022 Nov 3;15:6463-6470. doi: 10.2147/IDR.S385071. eCollection 2022.
Patients with cirrhosis from genotype 3 (GT3) hepatitis C virus (HCV) infection are difficult to cure. This study investigated the effectiveness and safety of sofosbuvir-velpatasvir (SOF/VEL) with and without ribavirin (RBV) in patients with GT3 HCV-infection-related cirrhosis from Xinjiang, China.
This study included 33 patients with GT3 HCV infected cirrhosis, who were treated with either SOF/VEL+RBV for 12 weeks (n = 27) or SOF/VEL alone for 24 weeks (n = 6) between January 2019 and June 2021. The primary endpoint was a sustained virological response at 12 weeks (SVR12), post-treatment. Secondary endpoints included changes from baseline in Child-Pugh-Turcotte scores, clinical results, hepatic-encephalopathy status, ascites, and gastrointestinal bleeding at 12 weeks, post-treatment.
Out of the 33 patients, 18 (54.6%) were diagnosed with GT3a, 15 (45.4%) with GT3b, 16 (48.5%) with compensated cirrhosis, and 17 (51.5%) with decompensated cirrhosis. SVR12 was 87.9% (compensated cirrhosis: 93.8%, decompensated cirrhosis: 82.4%). The Child-Pugh-Turcotte scores improved at 12 weeks (p < 0.05). Total bilirubin, albumin, and alanine transaminase levels, as well as hepatic-encephalopathy were significantly improved among patients with compensated and decompensated cirrhosis (p < 0.05). The blood cell count and serum creatinine levels did not deteriorate.
SOF/VEL, with and without RBV, was effective, safe, and well-tolerated as a treatment for GT3 HCV associated cirrhosis.
丙型肝炎病毒（HCV）基因3型（GT3）感染所致肝硬化患者难以治愈。本研究调查了索磷布韦-维帕他韦（SOF/VEL）联合或不联合利巴韦林（RBV）治疗中国新疆GT3 HCV感染相关肝硬化患者的有效性和安全性。
本研究纳入33例GT3 HCV感染肝硬化患者，于2019年1月至2021年6月期间，其中27例接受SOF/VEL+RBV治疗12周，6例仅接受SOF/VEL治疗24周。主要终点是治疗后12周的持续病毒学应答（SVR12）。次要终点包括治疗后12周时Child-Pugh-Turcotte评分相对于基线的变化、临床结果、肝性脑病状态、腹水及胃肠道出血情况。
33例患者中，18例（54.6%）诊断为GT3a，15例（45.4%）为GT3b，16例（48.5%）为代偿期肝硬化，17例（51.5%）为失代偿期肝硬化。SVR12为87.9%（代偿期肝硬化：93.8%，失代偿期肝硬化：82.4%）。Child-Pugh-Turcotte评分在12周时有所改善（p<0.05）。代偿期和失代偿期肝硬化患者的总胆红素、白蛋白、丙氨酸转氨酶水平以及肝性脑病均有显著改善（p<0.05）。血细胞计数和血清肌酐水平未恶化。
SOF/VEL联合或不联合RBV治疗GT3 HCV相关肝硬化有效、安全且耐受性良好。
