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. 2023 Apr 5;10(4):ofad178.
doi: 10.1093/ofid/ofad178. eCollection 2023 Apr.

A Randomized Clinical Trial of Transgender Women Switching to B/F/TAF: The (mo)BETTA Trial

Jordan E Lake  1 , Ana N Hyatt  1 , Han Feng  2 , Paula Debroy  1 , Aaren Kettelhut  3 , Hongyu Miao  2 , Liming Peng  4 , Shalender Bhasin  4 , Susan Bell  1 , Nahid Rianon  1 , Todd T Brown  5 , Nicholas T Funderburg  3
Affiliations

A Randomized Clinical Trial of Transgender Women Switching to B/F/TAF: The (mo)BETTA Trial

Jordan E Lake et al. Open Forum Infect Dis. .

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.

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Conflict of interest statement

Potential conflicts of interest. J.E.L. has received research support from Gilead Sciences related and unrelated to the work, research support from CytoDyn, Pfizer, and OncoImmune unrelated to the work, and consultancy support from Gilead Sciences, Merck and Co., and Theratechnologies (consultancy unrelated to the work). A.N.H.: No conflict. H.F.: No conflict. P.D.: No conflict. A.K.: No conflict. H.M.: No conflict. L.P.: No conflict. S.B.: No conflict. S.B.: No conflict. N.R.: No conflict. T.T.B. has served as a consultant to Merck, Gilead Sciences, ViiV Healthcare, Janssen, and Theratechnologies unrelated to the work. N.F. has served as a consultant for Gilead and has received research support from Gilead for unrelated work. All other authors report no potential conflicts.

Figures

Figure 1.
Figure 1.
Patient disposition. Abbreviations: ART, antiretroviral therapy; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; GI, gastrointestinal.
See this image and copyright information in PMC

References

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