CHMP recommends Apretude for prevention of sexually acquired HIV-1 in combination with safer sex practices.- Viiv Healthcare
The Committee for Medicinal Products for Human Use (CHMP)has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Apretude, intended for prevention of sexually acquired HIV-1 in combination with safer sex practices. The applicant for this medicinal product is ViiV Healthcare B.V.
Apretude will be available as a 30 mg film-coated tablet and a 600 mg prolonged-release suspension for injection. The active substance of Apretude is cabotegravir, an antiviral for systemic use (ATC code: J05AJ04). Cabotegravir is an integrase inhibitor of HIV-1 which inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration, which is essential for the HIV replication cycle.
The benefit of Apretude was a demonstrated superiority of injections every 2 months over a daily oral regimen of tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) in preventing acquisition of HIV-1 infection, with a 66% and an 88% risk reduction, as shown in two double-blind safety and efficacy studies. The most common side effects are injection site reactions, headache, diarrhoea, and increased transaminase levels.
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