1. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women
- Author
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Philip Sullivan, Adeola Adeyeye, Jeanne M. Marrazzo, James F. Rooney, David J. Margolis, Susan H. Eshleman, Jonathan Lucas, Suwat Chariyalertsak, Ha V Tran, Peter J. Anderson, Hyman M. Scott, Eric S. Daar, Nittaya Phanuphak, Beatriz Grinsztejn, Colleen F Kelley, Craig W. Hendrix, Jorge A Gallardo-Cartagena, J Valdez Madruga, Sheldon D. Fields, Aditya H Gaur, Joseph J. Eron, Myron S. Cohen, Christina Psaros, Paul G. Richardson, Kailazarid Gomez-Feliciano, Zhe Wang, Meredith E. Clement, Timothy H. Holtz, Alex R. Rinehart, Aida Asmelash, Steven A. Safren, Lara E. Coelho, Juan C Hinojosa, Roy M. Gulick, Hptn (PopART) Study Team, Eileen F. Dunne, Andrea Jennings, Javier Valencia Huamaní, Pedro Gonzales, Shobha Swaminathan, Kimberly Y. Smith, Estelle Piwowar-Manning, Deborah Donnell, Marcelo H. Losso, Marcus Bryan, Ryan Kofron, Esper G Kallas, Brett Hanscom, Leslie Cottle, Marybeth McCauley, Jeremy Sugarman, Carlos del Rio, Raphael J. Landovitz, Robinson Cabello, William Spreen, Cheryl Blanchette, Edgar T. Overton, Omar Sued, Katherine Shin, Maoji Li, Keren Middelkoop, Nirupama Sista, Mark A. Marzinke, Breno Santos, Ian Frank, and Todd T. Brown
- Subjects
Male ,Human immunodeficiency virus (HIV) ,Drug Resistance ,Administration, Oral ,HIV Infections ,medicine.disease_cause ,Medical and Health Sciences ,Transgender women ,Pre-exposure prophylaxis ,chemistry.chemical_compound ,Cabotegravir ,HPTN 083 Study Team ,Homosexuality ,Young adult ,media_common ,Intramuscular ,General Medicine ,Middle Aged ,Intention to Treat Analysis ,Infectious Diseases ,6.1 Pharmaceuticals ,Administration ,HIV/AIDS ,Female ,Patient Safety ,Transgender Person ,Infection ,Oral ,Adult ,medicine.medical_specialty ,Anti-HIV Agents ,Pyridones ,media_common.quotation_subject ,Clinical Trials and Supportive Activities ,Sexual and Gender Minorities (SGM/LGBT*) ,Injections, Intramuscular ,Transgender Persons ,Drug Administration Schedule ,Injections ,Medication Adherence ,Young Adult ,Double-Blind Method ,Clinical Research ,General & Internal Medicine ,medicine ,Humans ,HIV Integrase Inhibitors ,Homosexuality, Male ,Tenofovir ,Aged ,business.industry ,Prevention ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Multicenter study ,chemistry ,Family medicine ,Delayed-Action Preparations ,Pre-Exposure Prophylaxis ,business - Abstract
BackgroundSafe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection.MethodsWe conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection.ResultsThe intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified.ConclusionsCAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).
- Published
- 2021