中国HIV-1患者使用利匹韦林为基础抗病毒方案的长期疗效和安全性及耐受性  

Long-term efficacy,safety and tolerability of rilpivirine-based ART regimen in HIV-1 infected Chinese patients

作　　者：张宏伟 蔡卫平[2] 何浩岚[2] 卢洪洲 张仁芳 李兴旺[4] 吴焱[4] 黄晓婕 吴昊 ZHANG Hong-wei;CAI Wei-ping;HE Hao-lan;LU Hong-zhou;ZHANG Ren-fang;LI Xing-wang;WU Yan;HUANG Xiao-jie;WU Hao(Infectious Center,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Department of Infectious Disease,Guangzhou Eighth People's Hospital,Guangzhou 510060,China;Department of Infectious Disease,Shanghai Public Health Clinical Center,Shanghai 201500,China;Bejing Dian Hospital,Capital Medical University,Beijing 100011,China)

机构地区：[1]首都医科大学附属北京佑安医院感染中心,北京100069 [2]广州市第八人民医院感染科,广州510060 [3]上海公共卫生临床中心感染科,上海201500 [4]首都医科大学附属北京地坛医院,北京100011

出　　处：《中国新药杂志》2021年第2期145-149,共5页Chinese Journal of New Drugs

摘　　要：目的:评估利匹韦林(rilpivirine,RPV)联合2种核苷类逆转录酶抑制剂(NRTIs)对中国HIV-1型感染者的长期安全性、耐受性和疗效。方法:本研究为RPV开放多中心Ⅲ期延长研究TMC278-Ti DP6-C222的中国亚组分析,入组患者在既往RPVⅡb和Ⅲ期研究结束后签署知情同意自愿纳入延长研究,继续接受RPV 25 mg(qd)联合2 N[t]RTLs.RPV治疗的获益通过疗效以及安全性进行评估。结果:2011年2月25日起来自RPVⅡb和Ⅲ期研究共26例中国HIV-1型感染者进入C222延长研究,数据收录截止日期为2018年2月8日,平均随访6.07年。随访期间大部分不良反应为1或2级,只有2例(7.7%)患者报告出现3或4级不良反应,没有RPV相关严重不良反应报告。随访期间只有1例(3.8%)患者在96~120周出现一过性低病毒血症(242 copies·m L^(-1)),并在后面随访中恢复病毒载量(VL)<50 copies·m L^(-1)。所有患者在随访期间至少有一次CD4>500 cell·mL^(-1),除了192~240周之间短暂下降,整体CD4细胞计数持续缓慢增加到336周。结论:使用RPV 25 mg(qd)联合2 N(t) RTIs治疗,对于中国HIV-1型感染者有效,整体来讲安全性和耐受性良好。[Abstract]Objective:To evaluate the long-term safety,tolerability,and efficacy of antiretroviral therapy(ART) regimen with rilpivirine (RPV) combined with two nucleoside reverse transcriptase inhibitors (N[t]RTIs)in human immunodeficiency virus (HIV)-infected Chinese subjects.Methods:This is a Chinese subgroup study derived from the clinical study,TMC278-Ti DP6-C222,which is a phaseⅢopen-label multicenter,roll-over study.Patients received RPV 25 mg once daily (qd) in combination with two N[t]RTLs.The benefits from RPV treatment were evaluated by efficacy(HIV-1 RNA and CD+4cell count) and safety (AE,SAE).Results:Overall,26 HIV-1infected Chinese subjects were treated in this extended C222 study.AE leading to permanent discontinuation of study drug were reported in one (3.8%) subject.Most AEs were grade 1 or 2 in severity.Grade 3 or 4 AEs were reported in two (7.7%) subjects.No RPV-related serious AEs (SAEs) were reported.During follow-up,only one(3.8%) subject experienced a blip between week 96 to week 120 (242 copies·m L^(-1)) and then returned to VL<50 copies·m L^(-1)subsequently.All patients had at least one time of CD4>500 cell·m L^(-1)and the CD+4cell countgradually increased over time until week 336 except a decrease occurred between week 192 to week 240.Conclusion:Long-term treatment with RPV 25 mg qd in combination with two N (t) RTIs is effective,generally safe and well tolerated in Chinese adult patients with HIV-1 infection.

关 键 词：利匹韦林 长期疗效 耐受性 安全性 

分 类 号：R969.4[医药卫生—药理学] R978.7[医药卫生—药学]