HIV Revolution: FDA Approves Two Yearly Injections to Prevent Infection

The FDA, the American regulatory body, has approved lenacapavir, a six-monthly injection, which is able to protect against HIV infection in 99.9% of cases (two different studies, one 100% and one 99.9%) and which is a candidate to be able to effectively contribute to putting an end to the AIDS epidemic. The drug is already used to treat resistant patients, in whom the drugs currently in use cannot keep the virus under control. It is in fact important to point out that, unlike for example the HCV virus, which can be eradicated with the drugs currently available, in the case of HIV science has only managed to prevent the replication of the virus, which therefore remains in the body but without reproducing and therefore without becoming dangerous. So much so that it becomes Undetectable, undetectable and untransmissible: the famous acronym U=U.

What is Prep?

But now lecanapavir, from the American company Gilead, which has already announced that it has signed royalty-free voluntary licensing agreements with six generic drug manufacturers to produce and distribute the drug in 120 low-income countries, is approved as a preventive therapy to avoid infections, what is called PREP, pre-exposure prophylaxis. Which exists today - in reality for about ten years - but involves a pill a day with a fidelity to therapy that is often very poor. The launch of the drug, however, falls in a particular historical period and will have to face a series of obstacles, including the cuts proposed by the Trump administration to federal funding for AIDS prevention, especially in African and developing countries, which account for the majority of cases.

Fear of cuts

“We have the greatest option for prevention in the 44 years of the epidemic,” admitted Mitchell Warren , executive director of Avac, the organization that deals with HIV prevention, “and there is the risk that it will be taken away from us by the policies of the last 5 months.” With less money available, in fact, there is the risk that governments will focus on treating those who are already infected rather than preventing new infections.

Data in the world and in Italy

But let's get to the data: according to the WHO, in 2023 there were approximately 1.3 million new infections and there are 40 million people living with HIV. There were approximately 630,000 deaths. In the United States alone, there are 700 new cases and 100 HIV-related deaths every week. In Italy in 2023 there were 2,349 new diagnoses, almost 60% in the late phase, and 400-500 cases in children. These numbers are increasing after the pandemic. There are an estimated 140,000 people living with HIV, of which approximately 100-110,000 are undergoing treatment. The WHO goal for 2030 continues to be 95-95-95, that is, 95% of diagnoses, 95% of patients who know they are infected and 95% who achieve viral suppression with treatment. In Italy we are above 90% but not yet at 95 and it is worrying that HIV is not talked about much and that the risk of contracting the infection is underestimated, mainly from unprotected sexual intercourse and blood. So much so that the Ministry of Health, last March, presented a strategic plan to put an end to HIV infections, viral hepatitis and sexually transmitted diseases, also underlining the role of PrEP with the aim of increasing use and adherence in key populations, with the possibility of prescribing also in Check points managed by associations, as well as in PrEP clinics.

The other options

Lenacapavir – which made the cover of Science last January as the drug of the year 2024, is the second long-acting drug for the prevention of HIV, the other drug is called cabotegravir, from ViiV Healthcare, and consists of an injection every two months. Many public health experts obviously believe that a six-monthly injection allows to reach more people, even in places that are more difficult to reach and with results that have exceeded expectations since they have almost reached 100% efficacy.

Costs in the US

But let's get to the costs, costs that concern the United States, since the drugs must then also be approved by the European authority EMA, which is followed by the negotiation of the price with our AIFA. Lenacapavir to prevent the infection will be sold at a list price of 28,218 dollars, the generic pill costs about 1 dollar per dose and the other long-acting drug costs about 24 thousand dollars a year. Gilead commented that most users will not pay for PrEP, either for insurance coverage or for assistance programs. But patient organizations fear that insurance could put up barriers to access to more expensive drugs and therefore limit their availability.