ViiV Healthcare Gains Breakthrough Status for HIV PrEP

ViiV Healthcare’s investigational drug cabotegravir, an HIV pre-exposure prophylaxis (PrEP),  has received a Breakthrough Therapy designation from the FDA.

The long-lasting injectable drug earned the Breakthrough Therapy designation based on results from its phase 2b/3 trial that showed it was 66 percent more effective at preventing HIV compared to daily oral emtricitabine/tenofovir disoproxil fumarate.

The study involved 4,566 men who have sex with men and spanned research sites in the U.S., Argentina, Brazil, Peru, South Africa, Thailand and Vietnam.