Objective: To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis. Methods: An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs. Results: A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal. Conclusion: Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.
目的： 评估奥比帕利（奥比他韦/帕立瑞韦/利托那韦）25/150/100 mg，1次/d和达塞布韦（DSV）250 mg，2次/d联合利巴韦林在丙型肝炎病毒基因1b型感染的代偿期肝硬化中国大陆成年患者中的有效性和安全性。 方法： 采用开放标签、多中心III期临床试验，在中国大陆、中国台湾地区和韩国开展，纳入初治和经治基因1b型丙型肝炎病毒感染的代偿期肝硬化（Metavir评分纤维化分期= F4）成年患者，接受奥比他韦/帕立瑞韦/利托那韦和达塞布韦联合利巴韦林治疗12周。评估患者停药12周获得的持续病毒学应答（SVR）及24周获得的SVR率，并在接受至少1次研究药物的患者中评估有效性和安全性。 结果： 共纳入63例中国大陆患者，其中62例（98.4%）患者基线Child-Pugh评分为5分。患者总体SVR12率及SVR24率为100%（95% CI：94.3%～100.0%）。发生的大多数不良事件为轻度。常见（发生率≥10%）所有级别不良事件和实验室异常包括总胆红素升高（36.5%）、乏力（19.0%）、非结合胆红素升高（19.0%）、结合胆红素升高（17.5%）和贫血（14.3%）。3例（4.8%）患者发生≥3级不良事件，均被研究者判定为与研究药物无关。无患者出现导致提前停药的不良事件。 结论： 丙型肝炎病毒基因1b型感染的代偿期肝硬化中国大陆患者接受奥比他韦/帕立瑞韦/利托那韦和达塞布韦联合利巴韦林治疗12周，停药12周和24周的SVR均为100%。耐受性及安全性良好，大多数不良事件为轻度。.
Keywords: Direct-acting antiviral agents; Hepatitis C virus; Liver cirrhosis.