Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

August 12, 2021.

NEngl J Med 2021; 385: 595-608

DOI: 10.1056 / NEJMoa2101016

Commentary

This study was conducted to validate a safe and effective long-acting injectable drug for pre-exposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) infection.

A randomized, double-blind, double-dummy, non-inferiority study was conducted 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.

Subjects will include cisgender men who are at risk of having sex with men (MSM) and transgender women who are at risk of having sex with men, who will receive daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC).

Participants were randomly assigned (1:1) to receive one of two regimens and were followed for 153 weeks for HIV testing and safety assessments.

Of the 4566 participants who were randomized, 570 were transgender women, with a median age of 26 years.

Of the 1698 participants from the United States, 845 were identified as black, and incident HIV infection occurred in 52 participants.

There were 13 in the cabotegravir group and 39 in the TDF-FTC group. Efficacy was consistent across prespecified subgroups, with injection site reactions reported in 81.4% of participants in the cabotegravir group and 31.3% of participants in the TDF-FTC group.

No safety concerns were identified in participants whose HIV infection was diagnosed after exposure to CAB-LA, with INSTI resistance and delayed detection of HIV infection.

These conclusions show that CAB-LA is superior to daily oral TDF-FTC in preventing HIV infection in MSM and transgender women, but ways to prevent INSTI resistance when CAB-LA PrEP fails must be explored.