目的评估奥比帕利和达塞布韦在丙型肝炎病毒(HCV)基因1b型感染的无肝硬化或代偿期肝硬化患者真实世界中的疗效和安全性。方法采用真实世界研究方法,在中国广东省三家医疗中心进行研究。纳入HCV基因1b型初治和普通干扰素/聚乙二醇干扰素α联合利巴韦林经治的非肝硬化或代偿期肝硬化患者,接受奥比帕利联合达塞布韦治疗8周或12周。奥比他韦/帕立瑞韦/利托那韦(OBT/PTV/r)25/150/100 mg,1次/d,达塞布韦(DSV)250 mg,2次/d,评估患者停药12周获得的持续病毒学应答(SVR12)及治疗和随访期间的不良事件发生率。非正态分布的计量资料采用全距和中位数描述。结果截至2018年7月31日,共有80例HCV基因1b型患者纳入研究,其中88.8%(71/80)为初治患者、12.5%(10/80)为代偿期肝硬化患者,97.5%(78/80)患者接受了12周治疗方案、2.5%(2/80)患者接受了8周方案。随访至2018年10月30日,治疗结束时(EOT)的病毒学应答率为100%(64/64)。共67例完成了治疗结束后12周,有43例患者返院复诊,SVR12为100%(43/43)。治疗期间,无一例患者因不良反应而停药。结论奥比帕利联合达塞布韦治疗中国真实世界的HCV 1b型患者,EOT和SVR12均为100%,且耐受性和安全性良好。
ObjectiveTo evaluate the real-world safety and curative effect of ombitasvir combined with dasabuvir for the treatment of chronic hepatitis C 1b genotype infection in non-cirrhotic or compensated cirrhotic patients.MethodsA real-world research method was adopted, and the research was conducted at three medical centers of mainland China. Non- cirrhotic or compensated cirrhotic patients with HCV genotype 1b infection who were initially treated with IFN/PEG-IFN-alpha combined with ribavirin, and ombitasvir combined with dasabuvir for 8 or 12 weeks were taken. Sustained virological response (SVR) and the incidence of adverse events during treatment and follow-up were evaluated after 12 weeks of drug withdrawal at OBV/PTV/r 25/150/100mg once daily and DSV 250mg, twice daily. Median and range were used for description of non-normally distributed data.Results80 cases of GT1b were included in this study. Of these 88.8% (71/80) were newly diagnosed, 12.5% (10/80) were compensated cirrhotic, 97.5% (78/80) received 12 weeks treatment, and 2.5% (2/80) received 8 weeks treatment. The rate of HCV RNA negative at EOT (end of treatment) was 100% (64/64). A total of 67 patients completed the treatment within 12 weeks, and 43 patients returned to the hospital for further consultations, and SVR12 was 100%(43/43). No patient discontinued the drugs because of an adverse event during treatment.ConclusionIn the real world, Ombitasvir combined with dasabuvir for the treatment of chronic hepatitis C 1b genotype infection in China has 100% rates of EOT and SVR12 with well- tolerability and safety.
Chinese Journal of Hepatology
Hepatitis C, chronic
Direct-acting antiviral agent