Viiv’s Cabotegravir Shows Superiority Over Truvada as PrEP Among Women

Data from the Phase III study of ViiV Healthcare’s injected drug for pre-exposure prophylaxis (PrEP) against HIV infection among cisgender women will likely bolster its chances of winning regulatory approval across gender groups, following the release earlier this year of positive data in men who have sex with men (MSM) and transgender women. The bigger question now is how it will fit into the overall treatment paradigm, given competition from the two approved oral drugs.

ViiV said 9 November that the data safety monitoring board (DSMB) for the Phase III HPTN 084 study of cabotegravir as a PrEP treatment for women in sub-Saharan Africa had recommended the early termination of the trial after it had met its primary endpoint of showing superior HIV prevention compared with Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproximal fumarate) in an interim analysis. The study’s blinded phase had been designed to continue until 2022