Europe Commission Authorizes Cabotegravir for HIV Prevention

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This action paves the way for this long-acting injectable to be used in several countries on the European continent.

3 Key Takeaways

  • This approval is significant as it provides a new, innovative option for HIV prevention in high-risk adults and adolescents within the European Union (EU).
  • Instead of taking a daily pill, individuals can now benefit from as few as six injections per year, making adherence to the preventive regimen more convenient.
  • Clinical trials, including the HPTN 084 trial, have demonstrated that cabotegravir LA injectable is superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition.

This week, the European Commission authorized cabotegravir long-acting (LA) injectable and tablets (Apretude) for pre-exposure prophylaxis (PrEP) for HIV prevention. Cabotegravir is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV in high-risk adults and adolescents.

“This authorization 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,” Deborah Waterhouse, CEO at ViiV Healthcare, said. 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.”

According to the company, cabotegravir LA injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union (EU) that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year. Cabotegravir LA injectable and tablets for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition in clinical trials,

HPTN 084 trial

This trial is a phase 3 double blind superiority trial designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3224 cisgender women who are at increased risk of HIV acquisition. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the IM injection.

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in preventing HIV acquisition in the trial population. The most common adverse reactions (all grades) observed in at least 1% of subjects receiving long-acting cabotegravir were injection site reactions, diarrhoea, headache, fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting, myalgia, and rash.

With approximately 100,000 people newly diagnosed with HIV each year in Europe, expanding HIV prevention options is crucial in reducing HIV transmission.

In the US, cabotegravir was approved for PrEP usage in December 2021.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, stated at the time of the approval. “This injection, given every 2 months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”

Reference

European Commission Authorizes ViiV Healthcare’s Apretude (Cabtegravir Long-Acting and Tablets for HIV Prevention. ViiV. September 19, 2023. Accessed September 22, 2023. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2023/september/european-commission-authorises-viiv-healthcare/

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