Long-Acting HIV PrEP Receives Green Light in France

A long-acting injectable preventive treatment for HIV infection, considered a major step forward by associations and specialists, is now available in France following a government decree on February 26, 2026. This modern option addresses limitations of existing oral PrEP regimens and offers a more convenient approach to HIV prevention.

The Evolution of PrEP in France

Pre-exposure prophylaxis (PrEP), a preventive treatment for individuals exposed to HIV, has been available in France since January 2016 in tablet form [1]. However, adherence to daily oral PrEP can be challenging, leading to potential gaps in protection. France has seen positive outcomes with PrEP rollout, with adherence rates exceeding 81% and a significant drop in HIV incidence [4]. As of February 17, 2026, an estimated 84,997 PrEP initiations have occurred in France, all utilizing oral PrEP [2].

Cabotegravir: A New Approach to HIV Prevention

Injectable cabotegravir, marketed as Apretude by ViiV Healthcare (a GSK subsidiary), offers an alternative to daily pills. Administered every two months, it simplifies adherence and reduces the burden of treatment [1]. The French authorities recognize its value, providing 100% coverage for the treatment, despite its high cost – reportedly exceeding 1,000 euros per dose [1].

Regulatory Pathway and Approval

The approval process for injectable cabotegravir was lengthy, with a green light awaited for nearly two years. The French High Authority for Health (HAS) validated its clinical benefit in the summer of 2024, categorizing the improvement as “moderate.” Following this, price negotiations between health authorities and the laboratory were necessary before marketing could proceed [1]. Cabotegravir for PrEP was approved in 2023 [2], while Lenacapavir (LEN) for PrEP was approved in 2025 [2].

Reactions from Experts and Associations

The arrival of injectable PrEP has been widely welcomed by experts and advocacy groups. UNAIDS previously identified the drug as a potential “game changer” in HIV prevention [4]. The Aides association in France hailed it as a “major breakthrough,” particularly for individuals who struggle with adherence to daily oral PrEP [1].

Remaining Considerations and Limitations

Despite the enthusiasm, some limitations and concerns remain. A viral load test is required before initiating injectable PrEP, and this test is not fully covered, potentially incurring an additional cost for the individual [1]. The HAS does not currently recommend injectable cabotegravir for women of childbearing age due to a “potential risk of malformation” in the fetus. However, prescriptions may be considered on a case-by-case basis, with thorough counseling regarding risks and the necessity of effective contraception, alongside a mandatory pregnancy test before initiation [1].