Long-Acting HIV Prevention: Apretude Now Available in France

France has expanded its HIV prevention options with the approval and availability of Apretude (cabotegravir), the first long-acting injectable medication for pre-exposure prophylaxis (PrEP). This recent option offers a significant alternative to daily oral PrEP, potentially improving adherence and providing enhanced protection against HIV infection.

What is Apretude?

Apretude is an injectable form of cabotegravir, administered as a suspension for intramuscular injection. It is indicated for adults and adolescents weighing at least 35 kg who are at high risk of HIV-1 infection [1]. It’s designed to be used in conjunction with safer sex practices, such as consistent condom use.

How Does Apretude Work?

Apretude provides extended protection against HIV infection through a long-acting formulation of cabotegravir. The treatment regimen begins with two injections administered four weeks apart, followed by subsequent injections every eight weeks [3]. This differs significantly from the daily pill required with traditional oral PrEP methods.

Approval and Reimbursement in France

The Haute Autorité de Santé (HAS) approved the use of Apretude for HIV PrEP in France [3]. The HAS considers Apretude to offer a “minor improvement in medical service” (ASMR IV) compared to the standard emtricitabine/tenofovir disoproxil (Truvada) oral regimen [3]. Importantly, the treatment is now fully covered by the French national health insurance system (Sécurité sociale) [2].

Clinical Trial Results

The HAS decision was based on data from the HPTN 083 and HPTN 084 clinical trials. These studies demonstrated that Apretude was more effective than daily oral PrEP due to improved adherence to the preventative treatment regimen [3].

Availability and Formulation

Apretude is available in France as a suspension for injection. It is supplied in 3 ml glass vials, both individually (CIP: 34009 302 789 9 4) and in packs of 25 (CIP: 34009 550 974 2 6) [1].

Looking Ahead

The introduction of Apretude represents a significant advancement in HIV prevention strategies in France. By offering a long-acting injectable option, Apretude aims to address challenges related to daily adherence and provide a more convenient and effective means of protecting individuals at risk of HIV infection. Continued monitoring and research will be crucial to assess the long-term impact of Apretude on HIV incidence rates.