Faculty, Staff and Student Publications
Publication Date
4-1-2023
Journal
Open Forum Infectious Diseases
DOI
10.1093/ofid/ofad178
PMID
37096146
PMCID
PMC10122488
PubMedCentral® Posted Date
4-5-2023
PubMedCentral® Full Text Version
Post-print
Abstract
Background: Cardiometabolic disease in transgender women (TW) is affected by gender-affirming hormonal therapies (GAHTs), HIV, and antiretroviral therapy (ART). We evaluated the 48-week safety/tolerability of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs continued ART in TW on GAHT.
Methods: TW on GAHT and suppressive ART were randomized 1:1 to switch to B/F/TAF (Arm A) or continue current ART (Arm B). Cardiometabolic biomarkers, sex hormones, bone mineral density (BMD) and lean/fat mass by DXA scan, and hepatic fat (controlled continuation parameter [CAP]) were measured. Wilcoxon rank-sum/signed-rank and χ2 tests compared continuous and categorical variables.
Results: TW (Arm A n = 12, Arm B n = 9) had a median age of 45 years. Ninety-five percent were non-White; 70% were on elvitegravir or dolutegravir, 57% TAF, 24% abacavir, and 19% TDF; 29% had hypertension, 5% diabetes, and 62% dyslipidemia. There were no adverse events. Arm A/B had 91%/89% undetectable HIV-1 RNA at week 48 (w48). Baseline (BL) osteopenia (Arm A/B 42%/25%) and osteoporosis (17%/13%) were common, without significant changes. BL lean/fat mass were similar. At w48, Arm A had stable lean mass but increased limb (3 lbs) and trunk (3 lbs) fat (within-arm P < .05); fat in Arm B remained stable. No changes occurred in lipid or glucose profiles. Arm B had a greater w48 decrease (-25 vs -3 dB/m; P = .03) in CAP. BL and w48 concentrations of all biomarkers were similar.
Conclusions: In this cohort of TW, switch to B/F/TAF was safe and metabolically neutral, though greater fat gain occurred on B/F/TAF. Further study is needed to better understand cardiometabolic disease burden in TW with HIV.
Keywords
HIV, bictegravir, fat, randomized clinical trial, transgender women
Published Open-Access
yes
Recommended Citation
Lake, Jordan E; Hyatt, Ana N; Feng, Han; et al., "A Randomized Clinical Trial of Transgender Women Switching to B/F/TAF: The (mo)BETTA Trial" (2023). Faculty, Staff and Student Publications. 1158.
https://digitalcommons.library.tmc.edu/uthsph_docs/1158