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  

作　　者：An Liu Ruolei Xin Hongwei Zhang Lili Dai Ruojun(Esther)Wu Xi Wang Aixin Li Wei Hua Jianwei Li Ying Shao Yue Gao Zhangli Wang Jiangzhu Ye Gulimila A bu dou re xi ti Zaicun Li Lijun Sun 

机构地区：[1]Clinic of Center for Infection,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China [2]Institute of STD/AIDS Prevention and Control,Beijing Center for Disease Prevention and Control,Beijing 100013,China [3]Department of Chemistry,Colgate University,Hamilton NY,USA [4]Care Center,The Eighth Affiliated Hospital of Xinjiang Medical University,Urumchi,Xinjiang 830054,China

出　　处：《Chinese Medical Journal》2022年第22期2725-2729,共5页中华医学杂志（英文版）

基　　金：Gilead Sciences, including provision of the study drug, and the Capital Health Research and Development of Special Fund(No. 2022-1G-3015)。

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.

关 键 词：Post-exposure prophylaxis Human immunodeficiency virus Bictegravir/emtricitabine/tenofovir alafenamide Adverse event 

分 类 号：R512.91[医药卫生—内科学]