Long-acting cabotegravir PrEP: a time for cautious optimism.

Two large, international, randomised, double-blinded, placebo-controlled trials have demonstrated the superiority of long-acting cabotegravir versus oral daily tenofovir disoproxil fumarate plus emtricitabine as pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV. The blinded phases of both trials were stopped early due to increased efficacy of the injectable cabotegravir, with the HPTN 083 and 084 trials demonstrating 66% and 88% respective reductions in HIV incidence for long-acting PrEP compared with the then standard of care, oral daily PrEP. 1 Landovitz RJ Donnell D Clement ME et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021; 385: 595-608 Crossref PubMed Scopus (265) Google Scholar , 2 Delany-Moretlwe S Hughes JP Bock P et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022; 399: 1779-1789 Summary Full Text Full Text PDF PubMed Scopus (124) Google Scholar This finding is potentially game changing and provides an important alternative strategy for people who can access and take this drug. Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trialLong-acting injectable cabotegravir PrEP retained high efficacy for HIV prevention in men and transgender women who have sex with men during the first year of open-label follow-up, with a near-identical HR for HIV risk reduction between long-acting injectable cabotegravir and daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP during the first year after unblinding compared with the blinded period. Extended follow-up further defined the risk period for diagnostic delays and emergence of INSTI resistance. Full-Text PDF Open Access