GSK HIV prevention drug gets European Commission authorisation

Deborah Waterhouse, CEO at ViiV Healthcare, said, “This authorisation marks a pivotal milestone for people across the EU who could benefit from an innovative, long-acting HIV prevention option that may better suit their personal preferences. Long-acting PrEP, alongside other HIV prevention strategies, plays an important role in helping to address some of the challenges that people may have with oral PrEP options”.

This approval is supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men (MSM), transgender women and cisgender women who were at increased risk of sexually acquired HIV. The studies demonstrated that cabotegravir LA for PrEP was superior to daily oral FTC/TDF tablets, with clinical trial participants given cabotegravir LA for PrEP experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083 (12 vs 39; annual incidence: 0.37% vs 1.22%; HR 0.31 [CI: 0.16, 0.58]), and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084 (3 vs 36; annual incidence: 0.15% vs 1.85%; HR 0.10 [CI: 0.04, 0.27]).1,2,3,4

Cabotegravir LA for PrEP is approved for use in the US, Australia, South Africa, as well as a number of other countries, as Apretude. Submission to other regulatory agencies is on-going.