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目的 评估奥比帕利(奥比他韦/帕立瑞韦/利托那韦,OBV/PTV/r)25/150/100mg,1次/d,联合达塞布韦250mg,2次/d,在丙型肝炎病毒基因1b型感染的初治和经治非肝硬化中国成年患者中的有效性和安全性.方法 采用随机、双盲、安慰剂对照、多中心Ⅲ期临床试验,在中国大陆、韩国、中国台湾地区进行.纳入基因1b型初治和普通干扰素/聚乙二醇干扰素α联合利巴韦林经治非肝硬化患者,随机分为2组,分别接受OBV/PTV/r联合达塞布韦方案立即治疗12周(A组),或接受安慰剂治疗12周后再继续接受OBV/PTV/r联合达塞布韦方案治疗12周(B组).评估患者停药12周获得的持续病毒学应答(SVR12)及停药24周获得的持续病毒学应答(SVR24)率,及双盲阶段和开放标签阶段治疗后的不良事件和实验室异常发生率. 结果 共纳入410例中国大陆患者资料,按1∶1比例随机分至A组和B组(每组205例).A组(205例)中初治患者的SVR12及SVR24率均为99％ (95％CI:94.8％ ～ 99.8％),经治患者的SVR12及SVR24率均为100％ (95％ CI:96.3％～ 100％),不同基线特征对SVR12及SVR24率没有影响.发生的大多数不良事件为轻度,治疗期间≥3级实验室异常少见,主要包括丙氨酸氨基转移酶升高(双盲阶段A组2例)、天冬氨酸氨基转移酶升高(双盲阶段A组3例)和总胆红素升高(开放标签阶段B组1例),通常无症状,用药中断或停药后可恢复.仅有1例因不良事件停药(B组,开放标签阶段). 结论 疗程为12周的OBV/PTV/r联合达塞布韦方案治疗中国基因1b型初治和经治非肝硬化慢性丙型肝炎患者可获得99％～ 100％的SVR12及SVR24率,且耐受性和安全性良好.“,”Objective To evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily combined with dasabuvir 250mg,twice daily in non-cirrhotic Chinese adult patients with newly diagnosed and treated chronic HCV genotype 1b infection.Methods A randomized,double-blind,placebo-controlled,multicenter phase 3 clinical trial was conducted in mainland China,Korea,and Taiwan.Safety and efficacy of OBV/PTV/r plus DSV administered for 12 weeks were evaluated in a newly diagnosed and treated (interferon alpha/pegylated interferon alpha) and ribavirin non-cirrhotic adults with chronic HCVgenotype 1b infection.Patients randomly received OBV/PTV/r plus DSV for 12 weeks (Group A),or placebo for 12 weeks (Group B) followed by an open-label phase of OBV/PTV/r plus DSV for 12 weeks.Sustained response (SVR12) rate obtained at 12 weeks and (SVR24) 24 weeks after discontinuation of treatment,and the incidence of adverse events and laboratory abnormalities after double-blind and open-label phase treatment were assessed.Results A total of 410 cases of Chinese patients were included and randomly assigned to group A and B (with 205 cases in each group) in a 1∶1 ratio.The rates of SVR12 and SVR24 were 99％ (95％ CI:94.8％-99.8％) in the newly diagnosed patients in group A (205 patients) and the rates of SVR12 and SVR24 were 100％ in treated patients (95％ CI:96.3％-100％).Different baseline characteristics had no effect on SVR12 and SVR24 rates.Most of the adverse events occurred were mild,asymptomatic,and ≥ 3 laboratory abnormalities during treatment were rare,including elevation of alanine aminotransferase (2 cases in double-blind stage A group),aspartate aminotransferase (Double-blind stage A (3 cases) and total bilirubin (1 case in open-label phase B group);however,those mild adverse events could be recovered after drug withdrawal or discontinuation.onlyl person discontinued drugs due to adverse events (Group B,open-label phase).Conclusion The 12 weeks treatment course of OBV/PTV/r combined with DSV produced 99％ ～ 100％ rates of SVR12 and SVR24 in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection,and the tolerance and safety were good.