Saturday, April 20, 2024

European Union Approves Cabotegravir, a Ground-breaking HIV Prevention Therapy

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Cabotegravir, a breakthrough HIV prevention therapy, has been approved for use in high-risk adults and adolescents aged a minimum of 12 years who weigh at least 35 kg. This therapy is unique as it reduces the number of doses from 365 daily pills to a minimum of six injections annually, making it the first and only HIV prevention therapy of its kind approved in the European Union (EU).

ViiV Healthcare CEO Deborah Waterhouse lauded this approval as a pivotal milestone for people across the EU who could benefit from a long-acting HIV prevention option tailored to their personal preferences. She further emphasized the significance of long-acting PrEP (Pre-Exposure Prophylaxis) in complementing other HIV prevention strategies, addressing challenges that people may encounter with oral PrEP options.

The EU’s approval of Cabotegravir is supported by results from two global, actively controlled, multicenter, randomized, double-blind Phase IIb/III studies, HPTN 083 and HPTN 084. These studies assessed the efficacy and safety of long-acting Cabotegravir for PrEP in HIV-negative men who had sex with men, cisgender women, and transgender women who were at high risk of HIV.

In these studies, patients receiving daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200 mg/300 mg tablets were compared against those given Cabotegravir every eight weeks. The results demonstrated that Cabotegravir LA for PrEP was superior to the daily oral FTC/TDF tablets, as it had a lower rate of HIV acquisition.

Called Apretude in some regions, Cabotegravir has also been approved for use in Australia, South Africa, the US, and several other countries. Submissions for the approval of this long-acting version of Cabotegravir to other regulatory agencies are currently underway.

Cabotegravir is an integrase strand transfer inhibitor that inhibits the replication of HIV by preventing the viral DNA from integrating into the genetic material of human T-cells.

This approval marks a significant advancement in HIV prevention strategies. By reducing the number of doses required and providing a long-acting alternative to daily oral tablets, Cabotegravir offers a more feasible and effective prevention option for high-risk individuals. Its mechanism of inhibiting HIV replication further underscores its potential in combating the global HIV epidemic.

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