The European Commission has approved ViiV Healthcare’s Apretude (cabotegravir long-acting (LA) injectable and tablets) to prevent HIV (human immunodeficiency virus).
ViiV Healthcare is the specialist HIV company majority owned by GSK, with Pfizer and Shionogi as stakeholders.
Cabotegravir is approved for use in combination with safer sex practices as a pre-exposure prophylaxis (PrEP) method. Its purpose is to reduce the risk of sexually transmitted HIV-1 infection in high-risk adults and adolescents who are at least 12 years old and weigh a minimum of 35kg.
Cabotegravir LA (long-acting) is available in both injectable and tablet forms for PrEP. It is noteworthy as the first and only HIV prevention option approved within the European Union (EU) that reduces the frequency of doses required for effective HIV prevention. Instead of daily pills, Cabotegravir LA can be administered as few as six injections per year.
Clinical trials have demonstrated that Cabotegravir LA, in both its injectable and tablet forms for PrEP, offers superior efficacy in reducing the risk of HIV acquisition compared to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
The approval provides individuals in the EU with more choices for PrEP, making it a significant advancement in HIV prevention.
ViiV Healthcare CEO Deborah Waterhouse 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.
“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 of Cabotegravir for pre-exposure prophylaxis (PrEP) is based on data from two international phase IIb/III multicentre, randomised, double-blind, active-controlled studies known as HPTN 083 and HPTN 084.
The studies assessed the safety and efficacy of Cabotegravir LA (long-acting) for PrEP in HIV-negative individuals, including men who have sex with men (MSM), transgender women, and cisgender women who were at an increased risk of sexually acquired HIV.
The results from the studies demonstrated the superiority of Cabotegravir LA for PrEP when compared to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets:
In HPTN 083, participants who received Cabotegravir LA for PrEP experienced a 69% lower rate of HIV acquisition compared to those taking FTC/TDF tablets. The annual incidence of HIV infection was 0.37% for Cabotegravir LA vs. 1.22% for FTC/TDF tablets (Hazard Ratio [HR]: 0.31 [Confidence Interval (CI): 0.16, 0.58]).
In HPTN 084, participants who received Cabotegravir LA for PrEP experienced a remarkable 90% lower rate of HIV acquisition compared to those taking FTC/TDF tablets. The annual incidence of HIV infection was 0.15% for Cabotegravir LA vs. 1.85% for FTC/TDF tablets (HR: 0.10 [CI: 0.04, 0.27]).
The findings underscore the efficacy of Cabotegravir LA for PrEP in reducing the risk of HIV acquisition among individuals at higher risk of sexually transmitted HIV.
