Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial
Abstract
Background: The HIV Prevention Trials Network (HPTN) 083 trial demonstrated that long-acting cabotegravir (CAB-LA) was more effective than tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in preventing HIV in cisgender men and transgender women (TGW) who have sex with men. In this report, we characterize the TGW cohort included in HPTN 083. Methods: An enrollment minimum of 10% TGW was set for HPTN 083. Socio-demographic characteristics, use of gender affirming hormone therapy (GAHT), and behavioral assessments were conducted throughout the trial. Laboratory testing and safety evaluations were performed. This is a secondary analysis of the HPTN 083 study (NCT02720094). Findings: HPTN 083 enrolled 570 TGW (304 TDF/FTC; 266 CAB-LA). TGW were primarily from Asia (225/570; 39.5%) and Latin America (205/570; 36.0%); 57.9% (330/570) reported GAHT use. Intimate partner violence was common, and 47.4% (270/570) and 30.2% (172/570) reported emotional or physical abuse, respectively; 56.7% (323/570) reported a history of childhood sexual abuse. Approximately one-quarter of TGW disagreed that they were at risk for HIV, and 24.9% (142/570) screened in for depressive symptoms. Incidence rates of syphilis, rectal gonorrhea, and chlamydia was 16.3%, 11.7%, and 20.6%, respectively. Frequency of adverse events was comparable between arms. Nine seroconversions occurred among TGW during the study blinded phase (7 TDF/FTC; 2 CAB-LA); overall incidence was 1.20 per 100 person-years (HR:…
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Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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