HIV prevention, WHO guidelines on the first drug to be injected every 6 months

In 2024, the journal Science had called it 'the closest thing to an HIV vaccine'. Today, after the green light for the drug came last June from the US Food and drud Administration, the World Health Organisation recommends the use of injectable lenacapavir (Len) only twice a year, 'as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention'.

The WHO's new guidelines on the drug, the first which, thanks to two six-monthly injections, allows almost total protection against HIV, are published on the occasion of the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda. And they are aimed at providing decisive support in combating the epidemic that has claimed 44.1 million victims since the 1980s, according to Unaids. In 2024, there will be 40.8 million people living with HIV, of whom 31.6 million will have had access to antiretroviral therapies, while around 630,000 will have died..

The WHO guidelines on injectable lecanapavir arrive "at a critical time, when HIV prevention efforts have stagnated," they note from the Geneva-based organisation, "with an estimated 1.3 million new infections in the past year and a disproportionate impact on clou and priority populations, including prostitutes, men who have sex with men, transgender people, people who inject drugs, people in prison, and children and adolescents. The prospect for millions of individuals around the world to switch from oral therapies or other short-acting solutions to just two injections a year could now offer "a highly effective and long-lasting alternative", the organisation emphasises.

With only two doses per year, Len is therefore, according to the WHO, 'a transformative step forward in protecting people at risk of HIV, particularly those who face difficulties with daily adherence to treatment, stigma or access to healthcare. 'Although an HIV vaccine still seems a difficult goal to achieve, lenacapavir is the best solution,' comments WHO DG Tedros Adhanom Ghebreyesus. 'It is a long-acting antiretroviral that, as tests have shown, prevents almost all HIV infections among people at risk. The launch of the new guidelines, together with the recent Fda approval, marks a major step towards expanding access to this powerful tool. We are committed to working with countries and partners to ensure that this innovation reaches communities as quickly and safely as possible".

The issue, however, is to allow access to the breakthrough that could come with this twice-a-year injectable drug: hence the World Health Organisation's exhortation to governments, donors and glib partners to immediately implement its administration as part of national HIV combination prevention programmes, with contextual collection of data on uptake, adherence and 'real world' impact, i.e. in actual use by the population concerned.