Long-acting injectable PrEP: a first in France and Europe

A major breakthrough in prevention

A new option for high-risk adults and adolescents

On 26 February 2026, the Department of Health authorised the marketing of Apretude®, a cabotegravir-based medicine developed by the British pharmaceutical company ViiV Healthcare (GSK), and its full reimbursement by the National Health Service. It has been available since 2 March 2026. This drug, for which reimbursement received a favourable opinion from the French National Authority for Health (HAS) in 2024, is in fact deemed “irreplaceable and particularly costly”. It thus becomes the first long-acting injectable pre-exposure prophylaxis (PrEP) option against HIV available in France and Europe. It may thus serve as an alternative to oral PrEP, which is also reimbursed and already available.

Already recommended by the World Health Organisation (WHO) since 2022 and authorised by the European Medicines Agency (EMA) since 2023, this new option is aimed at adults and adolescents at high risk of HIV infection. It is administered as an intramuscular injection every two months. It should be noted that the range of injectable PrEP options could expand further in the coming years: the US pharmaceutical company Gilead Sciences has also developed its own long-acting molecule, lenacapavir, which is administered as a subcutaneous injection every six months. Lenacapavir was granted marketing authorisation in Europe by the European Commission in the summer of 2025, but its marketing and reimbursement in France are currently under review.

New offering, same challenges

The French Society for the Fight against AIDS (SFLS) already offers a practical prescribing guide for injectable PrEP. Professor Gilles Pialoux, vice-president of the SFLS, warns, however, that this “therapeutic innovation must be accompanied by organisational innovation, a reduction in social health inequalities and humility in the face of the complexity of care pathways ”. The same sentiment is echoed by the community NGO coalition Coalition PLUS, which, whilst welcoming the arrival of a long-acting injectable PrEP treatment—this time based on lenacapavir—in Kenya, stands firm: “A new treatment only becomes a public health victory if it is accessible, funded and rolled out on a large scale. ”

While the AIDES association also welcomes this news, Solenn Bazin, prevention and treatment advocacy officer, regrets that those eligible for this new treatment will have to undergo an HIV viral load test. “[These] viral load tests are not 100% covered by the National Health Service under PrEP. There will therefore be a co-payment for the individual, though this may be covered by a private health insurance scheme if the person has one.” A similar caution was expressed by the inter-association collective TRT5 CHV: “The potential benefits associated with the long duration of action must not be negated by discouraging care pathways or co-payments, which may even exceed those of oral PrEP. ”

However, measuring viral load allows for earlier identification of HIV infection than a standard serological test. This thus prevents the initiation of injectable PrEP during a seroconversion phase, a situation likely to promote the emergence of resistance and complicate the subsequent management of HIV infection. The AIDES association is also campaigning for the launch of a cohort study to gather as much data as possible on deployment and monitoring strategies. The European Network for HIV, Hepatitis and Emerging Infectious Diseases (NEAT-ID), for which ANRS MIE notably promoted the ANRS NEAT 001 clinical trial, could provide an opportunity at European level and across several French sites.

The role of ANRS MIE

Funding research in all its forms

In the past, ANRS MIE has funded and supported numerous landmark studies and clinical trials on PrEP: in particular the ANRS IPERGAY trial in 2012, which demonstrated the efficacy of on–demand oral PrEP; followed by the ANRS Prévenir cohort in 2017, whose final results were presented at the latest Conference on Retroviruses and Opportunistic Infections (CROI) in February 2026 in Denver.

Currently, the agency is funding or promoting five other clinical or implementation studies on PrEP – including ANRS 0410s CABOPrEP and ANRS 0029s SimpPrEP (see below). Furthermore, more than thirty research projects in public health and the humanities and social sciences, spanning several continents and often in partnership with community organisations, have been supported by ANRS MIE since 2009 – such as the ANRS 12415 QualiPrEP Cambodia study on the acceptability of PrEP in Cambodia in 2022. These projects primarily aim to evaluate the implementation of PrEP in real-world settings across different populations, contexts and regions.

Supporting research on lenacapavir

Since 2025, ahead of its authorisation by the US Food and Drug Administration (FDA), ANRS MIE has established a working group on lenacapavir. Coordinated by Professor Jean-Michel Molina, it brings together community representatives and multidisciplinary researchers working in different countries.

The working group’s mission is to identify research questions raised by the arrival of this long-acting preventive treatment and to develop research projects, ranging from clinical research to public health research. The results of this work will help guide public authorities in drawing up recommendations on the roll-out of this new PrEP.

What is PrEP?

Pre-exposure prophylaxis (PrEP) for HIV is a proven tool that forms an integral part of the strategy to prevent HIV infection:

• Among men who have sex with men (MSM) and transgender women;
• Among men and women in serodiscordant heterosexual couples, and in the general population at high risk;
• And among people who inject drugs (with a lower level of evidence).

Any doctor can prescribe HIV PrEP. A follow-up consultation must be carried out one month after starting PrEP, then every 3 to 6 months depending on the frequency of high-risk sexual activity. The occurrence of HIV infection whilst on PrEP is rare, and is mainly linked to poor adherence to the preventive treatment. It requires prompt specialist advice.

Find all the recommendations from the Haute Autorité de Santé (HAS), the National Council on AIDS and Viral Hepatitis (CNS) and the ANRS MIE below (in French):