Home » ViiV Healthcare Gains Breakthrough Status for HIV PrEP
ViiV Healthcare Gains Breakthrough Status for HIV PrEP
November 20, 2020
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.
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