Branded as Apretude by GSK, the cabotegravir injection 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.
About 100,000 people are diagnosed with HIV each year in Europe and expanding HIV prevention options is crucial in reducing HIV transmission, according to a GSK statement.
PrEP reduces the risk of getting HIV from sex by about 99% and of getting HIV from injection drug use by at least 74%.
It works by setting up fortified “walls” around white cells or CD4 cells, to offer protection within seven to 20 days after the first dose.
These walls keep HIV from crossing into the healthy cells and replicating. If HIV enters your body, it will be unable to breach the walls to gain access to the CD4 cells.
Cabotegravir long-acting injectable and tablet for PrEP is the first and only HIV prevention option approved by 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, according to the GSK statement.
The drug has has demonstrated “superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate” in reducing the risk of HIV acquisition in clinical trials, giving people in the EU more options for PrEP.
“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,” said Deborah Waterhouse, CEO at ViiV Healthcare.
“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.”
The approval was supported by data from two international trials that evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, 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, according to the company statement.
The medicine is approved in the US, Australia, South Africa, and other nations.