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.
Chin Med J (Engl). 2022 Nov 20;135(22):2725-2729. doi: 10.1097/CM9.0000000000002494.
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.
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.
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).
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.
ChiCTR.org.cn, ChiCTR2100048080.
单片制剂（STR）为预防人类免疫缺陷病毒（HIV）感染提供了一种方便的每日一次的治疗方案。在这里，我们研究了贝替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）三联复方 STR 用于中国人群暴露后预防（PEP）的安全性和耐受性。
这是一项在中国北京一家三级医院的性传播疾病和获得性免疫缺陷综合征诊所进行的前瞻性、开放性、单臂试验。需要 PEP 的成年人被开处 BIC/FTC/TAF 一片，每天一次，持续 28 天。在基线、第 2、4、8、12 和 24 周收集并分析临床和实验室数据。
在这项研究中，共有 112 名参与者入组，其中 109 名（97.3%）为男性，平均年龄为 30±8 岁。PEP 完成率为 96.4%（95%置信区间：91.1-99.0%）。两名参与者在服用两天后因源伴侣被确定为 HIV 阴性而停止 PEP。一名参与者因根据排除标准患有乙型肝炎病毒感染而被排除。一名参与者因个人决定而停药。截至第 24 周，没有参与者感染 HIV。通过自我报告，依从率为 98.9%（标准差 [SD]：3.3%），通过药物计数为 98.5%（SD：3.5%）。仅有 5 名参与者出现与研究药物相关的轻度临床不良事件（包括头痛、腹泻和恶心），4 名参与者的血清肌酐升高（1 级）。
在中国人群中，每日一次的 BIC/FTC/TAF 三联 STR 用于 PEP 是安全且耐受良好的，完成率和依从率均较高。BIC/FTC/TAF 可能是 PEP 的一个不错选择。
ChiCTR.org.cn，ChiCTR2100048080。
