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Title
HPTN 083 interim results: Efficacy of pre-exposure prophylaxis (PrEP) containing long-acting injectable cabotegravir (CAB-LA) is maintained across regions and key populations
Presenter
Beatriz Grinsztejn
Authors
B. Grinsztejn * (1), D. Donnell (2), M. Clement (3), B. Hanscom (2), L. Cottle (2), L. Coelho (4), R. Cabello (5), S. Chariyalestak (6), E. Dunne (7,8), I. Frank (9), A. Gaur (10), P. Gonzalez (11), T.V. Ha (12), J. Hinojosa (13), E. Kallas (14), C. Kelley (15), M. Losso (16), J. Valdez Madruga (17), K. Middelkoop (18), N. Phanuphak (19), J. Gallardo (20), B. Santos (21), O. Sued (22), J. Valencia Huanami (23), C. Hucks-Ortiz (24), N. Cardozo (22), L. Monteiro (25), K. Promjantuek (19), X. Mvula (26), D. Jones (27), S. Eshleman (28), C. Blanchette (29), J. Lucas (29), H. Scott (30), S. Fields (31), K. Gomez-Feliciano (29), A. Jennings (29), J. Rooney (32), W. Spreen (33), D. Margolis (33), A. Rinehart (33), A. Adeyeye (34), M. Cohen (35), M. McCauley (29), R. Landovitz (36), C. Vela (13), for the HPTN 083 Study Team
Institutions
(1) Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil, (2) Fred Hutchinson Cancer Institute, Seattle, United States, (3) Louisiana State University, Baton Rouge, United States, (4) Instituto de Pesquisa Clinica Evandro Changas-Fiocruz, Rio de Janeiro, Brazil, (5) Via Libre Clinical Research Center, Lima, Peru, (6) Chiang Mai University, Research Institute for Health Sciences, Chiang Mai, Thailand, (7) Center for Disease Control and Prevention, Atlanta, United States, (8) Silom Clinic, Bangkok, Thailand, (9) University of Pennsylvania, Philadelphia, United States, (10) St. Jude Children''s Research Hospital, Memphis, United Kingdom, (11) Asociacion Civil Impacta Salud y Educacion, Lima, Peru, (12) Health Center of Pho Yen, Pho Yen, Vietnam, (13) Asociación Civil Selva Amazónica, Iquitos, Peru, (14) University of Sao Paulo, Sao Paulo, Brazil, (15) Emory University School of Medicine, Atlanta, United States, (16) Hospital General de Agudos JM Ramos Mejia, Buenos Aires, Argentina, (17) Sao Paulo DST/AIDS CRS, Sao Paulo, Brazil, (18) Groote Schuur Hospital, Cape Town, South Africa, (19) Thai Red Cross AIDS Research Centre, Bangkok, Thailand, (20) CITBM CRS, Lima, Peru, (21) Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil, (22) Fundación Huésped, Buenos Aires, Argentina, (23) Barranco CRS, Lima, Peru, (24) JWCH Institute, Los Angeles, United States, (25) Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil, (26) Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa, (27) St. Jude Children''s Research Hospital, Memphis, United States, (28) Johns Hopkins University School of Medicine, Baltimore, United States, (29) FHI 360, Durham, United States, (30) San Francisco Department of Public Health, San Francisco, United States, (31) New York Institute of Technology, Old Westbury, United States, (32) Gilead Sciences, Foster City, United States, (33) ViiV Healthcare, Durham, United States, (34) Division of AIDS, NIAID, NIH, Clinical Prevention Research Branch, Rockville, United States, (35) University of North Carolina School of Medicine, Department of Medicine, Chapel Hill, United States, (36) University of California Los Angeles, UCLA Center for Clinical AIDS Research & Education, Los Angeles, United States

BACKGROUND: HPTN 083 is a phase 2b/3 randomized multicenter double-blind, double-dummy clinical trial of long-acting cabotegravir (CAB) compared to daily oral TDF/FTC for HIV PrEP; primary results have been presented. In this analysis we compare HIV incidence and efficacy of CAB-LA versus TDF/FTC in targeted subpopulations.
METHODS: HIV-negative cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men at increased HIV risk were randomized 1:1 to either active CAB + placebo TDF/FTC or active TDF/FTC + placebo CAB. Participants were offered open-label daily oral TDF/FTC after their last injection. Enrollment was pre-specified to include at least: 50% participants under age 30; 10% TGW; and 50% Black in the United States (US). Hazard ratios (HR) were estimated using Cox proportional hazard models.
RESULTS: Of the 4566 participants enrolled, 67% were < 30 years, 12% were TGW, 50% of the US population was Black. Fifty-two incident HIV infections were observed, 44 among participants < 30 years old (11 in the CAB-LA arm versus 33 in the TDF/FTC arm; HR: 0.32, 95%CI: 0.16, 0.63). Nine infections were observed among TGW, 2 in the CAB-LA arm and 7 in the TDF/FTC arm (HR 0.29, 95% CI: 0.06,1.41). Among Black US participants, 4 infections were observed in the CAB-LA arm versus 15 in the TDF/FTC arm (HR 0.28, 95%CI:0.10,0.83). Across regions, the HR (CAB-LA vs TDF/FTC) varied from 0.19 (95% CI:0.07,0.56) in the US to 0.54 (95% CI: 0.20,1.46) in Latin America (Figure).

CONCLUSIONS: HPTN 083 is the first study demonstrating efficacy for a long-acting PrEP agent. Pre-specified key subpopulations historically underrepresented in PrEP registrational trials were successfully enrolled and retained, fostering inclusion and equity in scientific development. CAB provided estimates of high levels of protection regardless of gender, region, or age.