典型文献
An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1
文献摘要：
Background::Single-tablet regimen (STR) provides a convenient once-daily regimen for the prevention of human immunodeficiency virus (HIV) infection. Here, we investigated the safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as a three-drug, STR for post-exposure prophylaxis (PEP) in Chinese individuals.Methods::This was a prospective, open-label, single-arm trial conducted in a sexually transmitted diseases and acquired immunodeficiency syndrome clinic of a tertiary hospital in Beijing, China. Adults requiring PEP were prescribed BIC/FTC/TAF one pill once a day for 28 days. Clinical and laboratory data were collected and analyzed at baseline, weeks 2, 4, 8, 12, and 24.Results::Of 112 participants enrolled in the study, 109 (97.3%) were male and the mean age was 30 ± 8 years. PEP completion was 96.4% (95% confidence interval: 91.1-99.0%). Two participants stopped PEP after 2 days because the source partner was identified as HIV uninfected. One participant was excluded due to hepatitis B virus infection according to the exclusion criteria. One discontinued due to the participant’s decision. No participant acquired HIV through week 24. Adherence was 98.9% (standard deviation [SD]: 3.3%) by self-reporting and 98.5% (SD: 3.5%) by pill count. Only five participants experienced mild clinical adverse events attributed to the study drug (including headache, diarrhea, and nausea) and four participants had elevated serum creatinine (grade 1).Conclusions::A once daily, STR of BIC/FTC/TAF used as PEP was safe and well-tolerated with a high rate of completion and adherence in Chinese. BIC/FTC/TAF may be a good option for PEP.Trial Registration::ChiCTR.org.cn, ChiCTR2100048080
文献关键词：
Post-exposure prophylaxis;Human immunodeficiency virus;Bictegravir/emtricitabine/tenofovir alafenamide;Adverse event
中图分类号：
作者姓名：
Liu An;Xin Ruolei;Zhang Hongwei;Dai Lili;Wu Ruojun (Esther);Wang Xi;Li Aixin;Hua Wei;Li Jianwei;Shao Ying;Gao Yue;Wang Zhangli;Ye Jiangzhu;A bu dou re xi ti Gulimila;Li Zaicun;Sun Lijun
作者机构：
Clinic of Center for Infection, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China;Institute of STD/AIDS Prevention and Control, Beijing Center for Disease Prevention and Control, Beijing 100013, China;Department of Chemistry, Colgate University, Hamilton NY, USA;Care Center, The Eighth Affiliated Hospital of Xinjiang Medical University, Urumchi, Xinjiang 830054, China
文献出处：
引用格式：
[1]Liu An;Xin Ruolei;Zhang Hongwei;Dai Lili;Wu Ruojun (Esther);Wang Xi;Li Aixin;Hua Wei;Li Jianwei;Shao Ying;Gao Yue;Wang Zhangli;Ye Jiangzhu;A bu dou re xi ti Gulimila;Li Zaicun;Sun Lijun-.An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1)[J].中华医学杂志（英文版）,2022(22):2725-2729
A类：
coformulated,bictegravir,alafenamide,ChiCTR2100048080,Bictegravir
B类：
An,open,label,evaluation,safety,tolerability,emtricitabine,tenofovir,post,exposure,prophylaxis,following,potential,human,immunodeficiency,virus,Background,Single,tablet,regimen,STR,provides,convenient,once,daily,prevention,HIV,infection,Here,investigated,BIC,FTC,TAF,three,drug,PEP,Chinese,individuals,Methods,This,was,prospective,single,arm,trial,conducted,sexually,transmitted,diseases,acquired,syndrome,tertiary,hospital,Beijing,China,Adults,requiring,were,prescribed,one,pill,days,Clinical,laboratory,data,collected,analyzed,baseline,weeks,Results,Of,participants,enrolled,study,male,mean,age,years,completion,confidence,interval,Two,stopped,after,because,source,partner,identified,uninfected,One,excluded,due,hepatitis,according,exclusion,criteria,discontinued,decision,No,through,Adherence,standard,deviation,by,self,reporting,count,Only,five,experienced,mild,clinical,adverse,events,attributed,including,headache,diarrhea,nausea,four,had,elevated,serum,creatinine,grade,Conclusions,used,well,tolerated,high,adherence,may,good,option,Trial,Registration,org,cn,Post,Human,Adverse
AB值：
0.539339
相似文献
机标中图分类号，由域田数据科技根据网络公开资料自动分析生成，仅供学习研究参考。
