Long-Acting HIV Prevention Now Available in France: A New Era in Combating the Virus
In a significant step forward in the fight against HIV, France has authorized the sale of cabotegravir, marketed as Apretude, a long-acting injectable medication for pre-exposure prophylaxis (PrEP). The decision, announced on February 26th, offers a new option for individuals at substantial risk of HIV infection, moving beyond the need for daily oral medication. The French Ministry of Health has committed to fully covering the cost of the treatment, recognizing its unique value and expense. This development arrives at a critical time, as global HIV prevention efforts have plateaued, with approximately 1.5 million new infections reported in 2021, according to the World Health Organization (WHO).
Apretude represents a paradigm shift in HIV prevention. Unlike traditional PrEP, which requires consistent daily pill intake, Apretude is administered via intramuscular injection every two months, offering a potentially more convenient and effective solution. What we have is particularly important as adherence to daily oral PrEP can be challenging, leading to inconsistent protection. The authorization follows positive recommendations from the Haute Autorité de Santé (HAS), the Agence nationale de recherches sur le sida (ANRS), and the Conseil national du sida et des hépatites virales (CNS), all of which highlighted the benefits of this innovative approach to prevention. However, the HAS currently does not recommend the medication for women of childbearing age due to potential risks of fetal malformation.
Addressing the Cost Barrier and Ensuring Access
The path to making Apretude available in France wasn’t without hurdles, primarily centered around its cost. Although the European Medicines Agency approved the injectable PrEP in 2023, and the HAS validated its benefits in 2024, the rollout was delayed pending negotiations with the manufacturer, ViiV Healthcare, regarding pricing. According to a government publication in the Journal officiel, ViiV Healthcare is charging €1,312 (approximately $1,425 USD as of February 27, 2026) per dose in France. This is significantly lower than the price tag in the United States, where it can exceed $4,000 per dose. Apretude has been available in the US since 2022.
To ensure equitable access, the French health authorities are taking steps to address potential financial barriers. The HAS has recommended expanding access to PrEP, including allowing nurse practitioners and midwives to prescribe the medication, making it available to minors without requiring parental consent, and ensuring access for vulnerable populations, including those without legal immigration status or health insurance. The association Aides has pointed out that a prerequisite for receiving Apretude injections is a viral load test for HIV, which is not fully reimbursed by the national healthcare system. This could result in out-of-pocket expenses for patients, although these costs may be covered by supplemental health insurance. Aides also highlights that their SPOT centers in cities like Montpellier, Marseille, Paris, and Lyon offer free HIV testing.
How Apretude Works and its Efficacy
Cabotegravir, the active ingredient in Apretude, is a long-acting injectable form of PrEP. The medication works by preventing HIV from establishing itself in the body. According to the WHO, the first two injections are administered four weeks apart, followed by injections every eight weeks thereafter. Clinical trials, including the HPTN 083 and HPTN 084 studies, demonstrated the efficacy of cabotegravir in preventing HIV infection among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men. Combined, these trials showed a 79% relative reduction in HIV risk compared to daily oral PrEP, particularly in situations where adherence to oral medication was a concern. The WHO recommends cabotegravir as a safe and highly effective prevention option for individuals at substantial risk.
Expanding PrEP Options: A Global Perspective
The approval of Apretude in France aligns with a growing global trend towards expanding PrEP options. The WHO’s recommendation in July 2022 spurred countries to consider integrating long-acting cabotegravir into their HIV prevention strategies. This is particularly crucial in regions where adherence to daily oral PrEP is low, or where access to healthcare is limited. The WHO also released new guidance on differentiated and simplified PrEP approaches to facilitate easier access, including strategies tailored to key populations such as sex workers, men who have sex with men, people who inject drugs, people in prisons, and transgender people, who account for 70% of global HIV infections.
Traditional PrEP, typically involving daily oral tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) combined with emtricitabine, remains a vital tool in HIV prevention. However, the convenience of a long-acting injectable offers a compelling alternative for many. The availability of both options allows healthcare providers to tailor prevention strategies to individual needs and preferences. Cabenuva, another formulation containing cabotegravir and rilpivirine, is a long-acting HIV treatment regimen, administered monthly or every other month, for individuals already living with HIV.
Looking Ahead: Challenges and Opportunities
While the introduction of Apretude in France is a cause for optimism, challenges remain. Ensuring widespread awareness of the new option, addressing potential logistical hurdles in administering the injections, and monitoring long-term efficacy and safety will be crucial. Continued efforts to reduce stigma surrounding HIV and PrEP are essential to encourage uptake and maximize the impact of these prevention strategies. The French health authorities will need to closely monitor the implementation of Apretude and adapt their approach based on real-world data and feedback from healthcare providers and patients.
The availability of Apretude marks a significant milestone in the ongoing fight against HIV. By offering a more convenient and potentially more effective prevention option, it empowers individuals to capture control of their health and reduces the risk of new infections. As with any new medical intervention, ongoing monitoring and evaluation will be essential to ensure its long-term success and maximize its impact on public health. The next step will be observing the uptake of Apretude within the French healthcare system and assessing its impact on HIV incidence rates in the coming years.
Have your say: What are your thoughts on the introduction of long-acting injectable PrEP? Share your comments below and help us continue the conversation. Don’t forget to share this article with your network to raise awareness about this important development in HIV prevention.