Transgender women (TGW) in HPTN 083: an evaluation of safety, efficacy, and gender affirming hormonal therapy (GAHT) interactions with long-acting cabotegravir (CAB-LA)

Title

Transgender women (TGW) in HPTN 083: an evaluation of safety, efficacy, and gender affirming hormonal therapy (GAHT) interactions with long-acting cabotegravir (CAB-LA)

Presenter

Beatriz Grinsztejn

Authors

B. Grinsztejn * (1), B. Hanscom (2), Z. Wang (2), D. Donnell (2), P. Richardson (3), P. Sullivan (3), S. Eshleman (3), A. Jennings (4), K. Gomez-Feliciano (4), K. Samitpol (5), E. Jalil (1), N. Cardozo (6), B. Maia (7), T. Khan (8), Y. Singh (9), J. Franks (10), J. Valencia (11), C. Psaros (12), S. Safren (13), N. Sanchez (14), J. Lucas (4), C. Blanchette (4), J. Rooney (15), A. Rinehart (16), S. Ford (17), A. Adeyeye (18), M. Cohen (19), M. McCauley (4), R. Landovitz (20), M. Marzinke (3)

Institutions

(1) FIOCRUZ, INI, Rio de Janeiro, Brazil, (2) Fred Hutch, Seattle, United States, (3) Johns Hopkins University, Baltimore, United States, (4) FHI 360, Durham, United States, (5) Institute of HIV Research and Innovation, Bangok, Thailand, (6) Fundaction Huesped, Buenos Aires, Argentina, (7) University of Sao Paulo, Faculdade de Medicina, Sao Paulo, Brazil, (8) Fenway Health, Boston, United States, (9) Desmond Tutu HIV Centre, Cape Town, South Africa, (10) Columbia University, New York, United States, (11) IMPACTA-Peru, Lima, Peru, (12) Harvard Medical School, Cambridge, United States, (13) Miami University, Miami, United States, (14) University of Pennsylvania, Philadelphia, United States, (15) GILEAD, Foster City, United States, (16) ViiV Healthcare, London, United Kingdom, (17) GlaxoSmithKline, Brentford, United Kingdom, (18) NIH, DAIDS, Bethesda, United States, (19) University of North Carolina, Chapel Hill, United States, (20) UCLA, Los Angeles, United States

BACKGROUND: HPTN 083 demonstrated a 66% reduced risk of HIV acquisition for long-acting injectable cabotegravir (CAB-LA) vs. daily oral TDF/FTC. As transgender women (TGW) remain a priority group for HIV prevention, we report the safety, prevention efficacy, and pharmacokinetics (PK) of CAB-LA in TGW during the blinded phase of HPTN 083.
METHODS: Participant characteristics, including history of interpersonal violence, HIV risk perception, and grade 2+ adverse events, were compared between TGW and the larger study cohort. CAB drug concentrations were measured in a subset of TGW with and without gender-affirming hormonal therapy (GAHT) to evaluate the potential impact of GAHT on CAB PK.
RESULTS: Of 4566 participants enrolled in HPTN 083, 570 (12.5%) were TGW (United States 21.9%, Latin America 36.0%, Asia 39.5%, and Africa 2.6%).During the study, 330 (57.9%) TGW reported GAHT use, with estradiol valerate (44.5%) and spironolactone (32.4%) most frequently reported. HIV incidence among TGW was 1.80% (TDF/FTC) and 0.54% (CAB-LA) during the blinded phase of HPTN 083 (hazard ratio: 0.34, 95%, CI 0.08-1.56).When compared to the larger HPTN 083 cohort, TGW experienced an increased frequency of sexual (56.7% vs. 45.4%), physical (30.2% vs. 19.2%), and emotional (47.4% vs. 36.4%) interpersonal violence, and lower self-perceived HIV acquisition risk (53.3% vs. 66.5%). CAB-LA was well tolerated in TGW; the frequency of grade 2+ adverse events did not differ between TGW receiving CAB-LA or TDF/FTC (92.5% vs. 88.8%). CAB drug concentrations were measured in a subset of TGW who received on-time CAB injections (23 not taking GAHT, 30 taking GAHT).CAB drug concentrations were comparable between the two groups, suggesting the lack of a GAHT effect on CAB PK (Figure 1).

CONCLUSIONS: CAB-LA is a safe and effective HIV prevention strategy for TGW. Initial findings suggest there is no impact of GAHT on CAB concentrations.

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