European Commission Approves GSK/Pfizer-Backed HIV Infection Prevention Drug

The European Commission has approved ViiV Healthcare's Apretude (cabotegravir long-acting (LA) injectable and tablets) for HIV prevention. 

Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg. 

ViiV Healthcare is majority owned by GSK plc GSK, with Pfizer Inc PFE and Shionogi as shareholders.

Cabotegravir LA injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year. 

Cabotegravir LA injectable and tablets for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition in clinical trials.

Cabotegravir LA for PrEP is approved for use in the U.S., Australia, South Africa, and many other countries as Apretude. 

Cabotegravir LA for PrEP is provided as an injection administered six times per year and initiated with a single 600 mg injection one month apart for two consecutive months. 

The recommended continuation dose after the second initiation injection is a single 600 mg injection every two months. Cabotegravir oral tablets may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine. 

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