Saturday, April 20, 2024

ViiV Healthcare Receives European Commission Approval for Innovative Long Acting HIV Prevention

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ViiV Healthcare has secured authorization from the European Commission for Apretude (cabotegravir long-acting injectable and tablets) to prevent HIV. This groundbreaking approval is a significant milestone in the field of HIV prevention.

Cabotegravir is designed for use in high-risk adults and adolescents, starting from the age of 12, who weigh a minimum of 35 kg. Notably, it represents the first and only HIV prevention therapy endorsed by the European Union (EU) that dramatically reduces the dosing regimen from 365 daily pills to just six annual injections.

Deborah Waterhouse, CEO of ViiV Healthcare, expressed the importance of this authorization, stating that it offers a pivotal HIV prevention option for individuals in the EU. Long-acting PrEP (pre-exposure prophylaxis) offers an alternative that better aligns with personal preferences, addressing some of the challenges faced by those using daily oral PrEP.

The approval is grounded in the outcomes of the global HPTN 083 and HPTN 084 Phase IIb/III studies. These studies rigorously evaluated the effectiveness and safety of cabotegravir long-acting as PrEP in high-risk populations, including HIV-negative men who have sex with men, cisgender women, and transgender women.

In comparison to patients receiving daily oral emtricitabine/tenofovir disoproxil fumarate tablets, cabotegravir offered the advantage of an injection every eight weeks. This innovative approach to HIV prevention is poised to make a significant impact in the fight against HIV transmission.

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