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
10.1097/CM9.0000000000002494
- VernacularTitle: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
- Author:
An LIU
1
;
Ruolei XIN
;
Hongwei ZHANG
;
Lili DAI
;
(Esther) Ruojun WU
;
Xi WANG
;
Aixin LI
;
Wei HUA
;
Jianwei LI
;
Ying SHAO
;
Yue GAO
;
Zhangli WANG
;
Jiangzhu YE
;
A bu dou re xi ti Gulimila
;
Zaicun LI
;
Lijun SUN
Author Information
1. Clinic of Center for Infection, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
- Keywords:
Post-exposure prophylaxis;
Human immunodeficiency virus;
Bictegravir/emtricitabine/tenofovir alafenamide;
Adverse event
- From:
Chinese Medical Journal
2022;135(22):2725-2729
- CountryChina
- Language:Chinese
-
Abstract:
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
