奥比帕利联合达塞布韦治疗基因1b型慢性丙型病毒性肝炎患者的疗效与安全性分析

Efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir combined with Dasebuvir in patients with chronic hepatitis C geneotype 1b

目的评估广东地区奥比帕利联合达塞布韦治疗基因1b型慢性丙型肝炎患者(CHC)的临床疗效和安全性。方法以多中心的研究方式,按照统一的诊断标准和方法对2017年11月至2019年4月就诊于广东地区4所医院的61例基因1b型慢性丙型肝炎患者。给予奥比帕利(奥比他韦/帕立瑞韦/利托那韦)25/150/100 mg,1次/d,达塞布韦250 mg,2次/d,60例患者接受了12周治疗方案,1例患者接受了8周方案,治疗结束后随访12周,主要临床终点为治疗结束后12周获得持续病毒学应答(SVR12)的比例和不良事件(AE)发生率。结果治疗4周,91.8%(56/61)患者HCV RNA达到检测下限以下;治疗12周,100%患者HCV RNA检测不到,治疗结束后12周,SVR12率亦为100%;发生的大多数不良事件为轻度,实验室异常主要包括血小板计数下降(2例,3.3%),血红蛋白下降(1例,1.6%)。结论奥比帕利联合达塞布韦治疗在丙型肝炎病毒基因1b型患者中具有极好的临床疗效,耐受性及安全性良好。

Objective To evaluate the clinical efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir(OBV/PTV/r)combined with Dasebuvir(DSV)in the patients with genotype-1b chronic hepatitis C(CHC)in Guangdong.Methods This was a multi-center study including 61 patients with genotype 1b CHC registered to four hospitals in Guangdong between November 2017 and April 2019,based on uniform diagnostic criteria and treatment strategy.The patients were given OBV/PTV/r(25/150/100 mg)once daily plus dasebuvir 250 mg twice daily.A total of 60 patients were on the 12-week protocol,and one was on the 8-week protocol.After the treatment,the patients were followed up for 12 weeks.The major clinical endpoints were sustained virological response(SVR12)and incidence of adverse events(AE)at 12 weeks after the end of treatment.Results At 4 weeks of treatment,the HCV RNA was below the lower limit of detection in 91.8%(56/61)of the patients;at 12 weeks of treatment,the HCV RNA was undetectable in 100% of the patients.At 12 weeks after the end of treatment,the SVR12 rates were also 100%;most of the adverse events recorded were mild.Abnormal laboratory findings chiefly included lowered platelet counts(n=2,3.3%),and hemoglobins(n=1,1.6%).Conclusion OBV/PTV/r combined with DSV leads to excellent clinical efficacy in patients with genotype 1b CHC,with good patient tolerance and safety.