Patel Nimish, Morris Sheldon, Burke Leah, Chow Karen, Pacheco Deedee, Anderson Peter, Stancyzk Frank, Blumenthal Jill
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, California, USA.
School of Medicine, University of California San Diego, La Jolla, California, USA.
Br J Clin Pharmacol. 2024 Oct;90(10):2360-2365. doi: 10.1111/bcp.16071. Epub 2024 Apr 22.
Many transgender and gender diverse (TGD) individuals have expressed concerns about the potential for oral pre-exposure prophylaxis to affect hormonal concentrations achieved from taking gender-affirming hormone therapy (GAHT). The purpose of this study was to understand the bidirectional effects between hormone and intraerythrocytic tenofovir diphosphate concentrations when switching from tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to tenofovir alafenamide/emtricitabine (TAF/FTC) in TGD users/nonusers of GAHT.
The study evaluated stored blood samples and dried blood spot cards from TGD adults without HIV who took ≥12 weeks of TDF/FTC and then switched to ≥12 weeks of TAF/FTC for pre-exposure prophylaxis.
Thirty-nine individuals met the study inclusion criteria. Regardless of sex assigned at birth and the use of GAHT, there were no significant differences in hormone concentrations when individuals taking GAHT were taking TDF/FTC and then switched to TAF/FTC. Further, there was no significant difference in intraerythrocytic tenofovir diphosphate concentrations between users and nonusers of GAHT.
There are no bidirectional effects between hormone and intraerythocytic tenofovir diphosphate concentrations when switching from TDF/FTC to TAF/FTC in TGD users/nonusers of GAHT.
许多跨性别者和性别多样化者(TGD)对暴露前口服预防药物可能影响接受性别确认激素疗法(GAHT)所达到的激素浓度表示担忧。本研究的目的是了解在GAHT使用者/非使用者中,从替诺福韦酯/恩曲他滨(TDF/FTC)转换为替诺福韦艾拉酚胺/恩曲他滨(TAF/FTC)时,激素与红细胞内替诺福韦二磷酸浓度之间的双向影响。
该研究评估了来自未感染艾滋病毒的TGD成年人的储存血样和干血斑卡片,这些人服用TDF/FTC≥12周,然后转换为TAF/FTC≥12周进行暴露前预防。
39人符合研究纳入标准。无论出生时的性别指定以及GAHT的使用情况如何,服用GAHT的个体在服用TDF/FTC然后转换为TAF/FTC时,激素浓度均无显著差异。此外,GAHT使用者和非使用者之间红细胞内替诺福韦二磷酸浓度无显著差异。
在GAHT使用者/非使用者中,从TDF/FTC转换为TAF/FTC时,激素与红细胞内替诺福韦二磷酸浓度之间不存在双向影响。