达诺瑞韦联合索磷布韦治疗慢性丙型肝炎的真实世界临床研究  

A real-world clinical study of Danoprevir plus Sofosbuvir for chronic hepatitis C

作　　者：冯凯 黄平[2] 柯柳[3] 龙英姿[4] 杨晓冬 林潮双[1] FENG Kai;HUANG Ping;KE Liu;LONG Yingzi;YANG Xiaodong;LIN Chaoshuang(The Third Affiliated Hospital of Sun YatSen University,Guangzhou 510500,China;Lianjiang People′s Hospital,Lianjiang 524400,China;不详)

机构地区：[1]中山大学附属第三医院,广州510500 [2]廉江市人民医院,广东廉江524400 [3]柳州市人民医院,广西柳州545006 [4]广州市第八人民医院,广州510060 [5]昆明市第三人民医院,昆明650000

出　　处：《实用医学杂志》2021年第18期2418-2422,共5页The Journal of Practical Medicine

摘　　要：目的全口服直接抗病毒方案已经成为慢性丙型肝炎(CHC)治疗的首选。本研究旨在评价利托那韦增强的达诺瑞韦(DNVr)联合索磷布韦(SOF)±利巴韦林(RBV)治疗基因1、2、3、6型,非肝硬化及代偿期肝硬化慢性丙型肝炎患者的疗效和安全性。方法自2018年7月至2019年12月,选择在中山大学附属第三医院、昆明市第三人民医院、柳州市人民医院以及广州市第八人民医院四家中心登记的58例慢性丙型肝炎患者。所有患者均处方达诺瑞韦联合索磷布韦加或不加利巴韦林方案治疗12周,随访12周。主要终点是治疗结束12周后持续病毒学应答率(SVR12)。次要终点是治疗结束时的病毒学应答率(EOT)和不良事件发生率。结果58例患者中,GT1a占5.2%(n=3);GT1b占43.1%(n=25);GT2a占17.2%(n=10);GT3a占5.2%(n=3);GT3b占8.6%(n=5);GT6a占20.7%(n=12)。其中4例患者存在代偿期肝硬化。所有患者完成12周治疗,且结束治疗时HCV RNA低于检测下限(LLOQ<15 IU/mL)。有5例患者未能完成12周随访,完成随访的53例患者全部获得持续病毒学应答(SVR12:100%)。对于代偿性肝硬化患者,用达诺瑞韦联合索磷布韦加利巴韦林方案治疗12周,SVR12为100%(4/4)。在治疗和随访期间未观察到严重不良事件。仅有5例患者出现轻度不良反应。结论达诺瑞韦联合索磷布韦加或不加利巴韦林方案治疗基因1、2、3、6型慢性丙型肝炎患者SVR12高达100%(53/53),安全性及耐受性良好。Objective All-oral direct-acting antiviral therapies are becoming the choice for hepatitis C(HCV) treatment.In this study,we aimed to evaluate the efficacy and safety of ritonavir-boosted danoprevir(DNVr) plus sofosbuvir±ribavirin(RBV) in the treatment of patients with HCV genotype 1,2,3 or 6,non-cirrhotic and compensated cirrhosis.Methods From July 2018 to December 2019,we registered 58 patients with HCV from the Third Affiliated Hospital of Sun Yat-Sen University,Kunming Third People’ s Hospital,Liuzhou People’ s Hospital and Guangzhou Eighth People’ s Hospital.All patients were treated with DNVr plus sofosbuvir±ribavirin for12 weeks and then followed up for 12 weeks.The primary endpoint was the rate of sustained virologic response at week 12 after the end of treatment(SVR12).The secondary endpoint was virologic response rate at end-of-treatment(EOT) and adverse event outcome.Results Of the 58 patients who were enrolled,5.2%(n=3) had genotype la;43.1%(n=25) had genotype lb;17.2%(n=10) had genotype 2 a;5.2%(n=3) had genotype 3 a;8.6%(n=5) had genotype 3 b;and 20.7%(n=12) had genotype 6 a.There were 4 patients with compensated cirrhosis.All patients completed 12 weeks of treatment and ended with HCV RNA below the detection threshold(LLOQ <15 IU/ML).Five patients did not complete the 12-week follow-up,and all 53 patients who completed the follow-up achieved a sustained virologic response(SVR12:100%).For patients with compensated cirrhosis,12 weeks of treatment with Danorelbine plus Sulfofovir plus Ribavirin,SVR12 was 100%(4/4).No serious event was observed during the treatment and follow-up.Only 5 patients had mild adverse events.Conclusions DNVr plus sofosbuvir±ribavirin provided 100%(53/53) SVR12 in patients with HCV genotype 1,2,3 or 6 were safe and were well tolerated.

关 键 词：达诺瑞韦 利托纳韦 索磷布韦 丙型肝炎 持续病毒学应答 

分 类 号：R512.6[医药卫生—内科学]