EC approves Cabotegravir LA by ViiV Healthcare for HIV prevention

ViiV Healthcare, majorly owned by GSK with Pfizer and Shionogi as shareholders, announced that the European Commission (EC) has authorized Apretude, also known as cabotegravir long-acting (LA) injectable and tablets, for HIV prevention. This revolutionary treatment is now the only approved HIV prevention option in the European Union that offers an alternative to 365 daily pills, needing just six injections per year for effective HIV prevention.

Cabotegravir LA’s Efficacy Proven in Clinical Trials

Cabotegravir LA injectable and tablets have been indicated for pre-exposure prophylaxis (PrEP) in combination with safer sex practices. This approval comes on the back of multiple international phase IIb/III trials, including HPTN 083 and HPTN 084, that have shown its superior efficacy over daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing HIV risk. 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.”

Cabotegravir LA for PrEP’s Global Acceptance

Cabotegravir LA for PrEP has already been approved in the United States, Australia, South Africa, and various other countries as Apretude. Submission to other regulatory agencies is currently in progress.

Mechanism of Cabotegravir LA and Dosage Recommendations

Cabotegravir LA for PrEP works as an integrase strand transfer inhibitor (INSTI), preventing HIV replication. The treatment starts with a single 600 mg injection given one month apart for two consecutive months, followed by a single 600 mg injection given every two months. Oral tablets of cabotegravir may also be administered before the injections to assess tolerability.