Cabotegravir gets FDA 'Breakthrough' status for HIV PrEP

GlaxoSmithKline (LSE: GSK) majority-owned HIV specialist ViiV Healthcare says that the US Food and Drug Administration has granted Breakthrough Therapy designation for its long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP).

The designation was based on efficacy and safety results from HPTN 083, a Phase IIb/III randomized, multicenter, double-blind, clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200mg and 300mg (FTC/TDF) for HIV prevention among men who have sex with men and transgender women who have sex with men.

Final analysis of HPTN 083 showed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. This translated to an HIV incidence rate of 0.41% in the cabotegravir group (95% confidence interval [CI] 0.22%-0.69%) and 1.22% in the FTC/TDF group (95% CI 0.87%-1.67%) in a study population of 4,566.