The landscape of HIV prevention has seen a significant shift with the introduction of Apretude the first injectable PrEP (Pre-Exposure Prophylaxis) available in France. Since, this innovative treatment has been covered by the French Social Security system offering a new option for those at risk of HIV infection.
Apretude, which uses cabotégravir is administered every two months, providing a long-lasting alternative to daily oral PrEP. This development is part of a broader effort to expand prevention strategies and make HIV protection more accessible. But who is eligible for this new treatment, and how does it compare to traditional methods?
Who Can Benefit from Injectable PrEP?
The Haute Autorité de santé in France has recommended Apretude as an alternative for individuals who find daily oral PrEP challenging. This includes people who struggle with daily medication routines, such as those involved in chemsex drug users, sex workers, migrants, and individuals who face stigma and need to hide their PrEP use. Additionally, Apretude is suitable for those with renal or bone fragility as well as individuals who have difficulty swallowing pills or absorbing oral PrEP due to digestive surgeries.
Valérie Grange Director of Public Affairs at Viiv Healthcare the company behind Apretude, emphasizes the importance of finding the best prevention option for each individual. “The goal is to expand PrEP coverage as much as possible,” she states, highlighting the need for tailored solutions in HIV prevention.
Efficacy and Safety of Injectable PrEP
When used correctly, Apretude offers the same level of protection against HIV as oral PrEP. In fact, its injectable form may be more effective due to the elimination of daily dosing, which reduces the risk of missed doses. However, it’s important to note that full protection is only achieved seven days after the first injection. Additionally, neither Apretude nor oral PrEP protects against other sexually transmitted infections or hepatitis B, although a vaccine is available for the latter.
There are few medical contraindications for Apretude. It is not recommended for individuals who are HIV-positive or have an unknown HIV status, as well as those with known hypersensitivity to the treatment. Apretude is also incompatible with certain tuberculosis medications and anti-epileptic drugs. Furthermore, it is not advised for individuals on high-dose anticoagulants due to the risk of hematomas or hemorrhages, or for those with fessier prostheses.
Prescription and Follow-Up
Any experienced physician, whether a general practitioner or specialist in HIV care, can prescribe Apretude. Before starting the treatment, a comprehensive blood test is required to rule out any existing HIV infection, as injecting Apretude in an infected individual could lead to resistance to certain HIV treatments. The test also screens for other sexually transmitted infections and checks renal and liver function.
The treatment begins with two injections spaced one month apart, followed by injections every eight weeks. Regular biological follow-ups are necessary throughout the treatment, initially every two months and then every four months. It’s crucial to discuss the discontinuation of Apretude with a healthcare provider, as the drug can remain in the body at very low doses for nearly a year.
Comfort and Cost
The injection is administered intramuscularly in the fessier muscle, similar to a standard vaccine shot. While the needle is relatively large, the injection is generally well-tolerated. Some discomfort at the injection site may last for one or two days, but studies show that these symptoms diminish with time and repeated use. Apretude is generally well-tolerated, with minor and temporary side effects such as headaches or mild fever.
In terms of cost, Apretude is fully covered by the French Social Security system, as well as by the Complémentaire Santé Solidaire (CSS) and the Aide Médicale de l’État (AME). However, the necessary HIV viral load test before prescription is only 65% reimbursed, except for AME beneficiaries. This test is free in centers like CeGIDDSpotCheckpoint and Le Griffon but the Aides association notes that this requirement can be a barrier for some populations. There is hope that this obligation may be lifted in Europe in the future, as it has been in the United States.
The Future of Injectable PrEP
The introduction of Apretude marks a significant step forward in HIV prevention. As research continues, new formulations and dosing schedules are being explored. For instance, the EXTEND 4M study is investigating a new intramuscular cabotégravir formulation that could be administered just three times a year, further reducing the burden of regular clinic visits while maintaining regular screening and care.
With ongoing studies and real-world data, the future of injectable PrEP looks promising. As Valérie Grange notes, “The data presented at AIDS 2026 underscore the depth and breadth of evidence ViiV Healthcare has generated for long-acting injectables across HIV treatment and prevention.” This innovation not only offers a convenient alternative to daily oral PrEP but also has the potential to reach populations that have been underserved by traditional prevention methods.
