Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
J Gastroenterol Hepatol. 2018 Mar;33(3):710-717. doi: 10.1111/jgh.13912.
The real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) remain limited for East Asian hepatitis C virus genotype 1b (HCV-1b) patients. The study aimed to evaluate the antiviral responses of PrOD-based regimens for HCV-1b patients in Taiwan.
The study performed a retrospective analysis of 103 HCV-1b patients receiving PrOD with or without ribavirin (RBV) for 12 weeks. Data were analyzed to assess the on-treatment and off-therapy HCV viral load and on-treatment adverse events. The pre-specified characteristics related to sustained virologic response 12 weeks off therapy (SVR ) were compared.
At treatment week 4, 100 of 102 patients (98.0%) had serum HCV RNA level < 25 IU/mL. The SVR was achieved in 101 of 103 patients (98.1%, [95% confidence interval: 93.2-99.5%]). All except one (99.0%) patients tolerated treatment well without treatment interruption. One cirrhotic patient discontinued treatment at week 1 due to hepatic decompensation. Twenty-four patients (23.3%) had ≥ grade 2 elevation in total bilirubin levels, and 21 of them (87.5%) had indirect type hyperbilirubinemia. The stratified SVR rates were comparable in terms of sex, age, body mass index, prior treatment experience, hepatitis B virus surface antigen status, RBV usage, baseline and week 2 viral load, renal function, and hepatic fibrosis stage.
Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without RBV are efficacious and generally well tolerated for treatment of HCV-1b patients in Taiwan.
帕利瑞韦/利托那韦、奥比他韦和达塞布韦（PrOD）在东亚丙型肝炎病毒 1b 型（HCV-1b）患者中的真实世界疗效和安全性仍然有限。本研究旨在评估 PrOD 方案治疗台湾 HCV-1b 患者的抗病毒反应。
本研究对 103 例接受 PrOD 联合或不联合利巴韦林（RBV）治疗 12 周的 HCV-1b 患者进行了回顾性分析。对治疗期间和治疗结束后的 HCV 病毒载量以及治疗期间的不良反应进行了分析。比较了与治疗结束后 12 周持续病毒学应答（SVR）相关的预先指定特征。
在治疗第 4 周时，102 例患者中有 100 例（98.0%）血清 HCV RNA 水平<25 IU/mL。103 例患者中有 101 例（98.1%[95%置信区间：93.2-99.5%]）达到 SVR。除 1 例（99.0%）患者因肝性失代偿而在第 1 周中断治疗外，其余患者均能耐受治疗而未中断治疗。24 例（23.3%）患者总胆红素水平升高≥2 级，其中 21 例（87.5%）为间接型高胆红素血症。在性别、年龄、体重指数、既往治疗经验、乙型肝炎表面抗原状态、RBV 使用、基线和第 2 周病毒载量、肾功能和肝纤维化分期方面，分层 SVR 率无显著差异。
帕利瑞韦/利托那韦、奥比他韦和达塞布韦联合或不联合 RBV 治疗台湾 HCV-1b 患者是有效且通常可耐受的。
