The verdict of the regulatory body on the drug injectable every six months that offers total protection from the contagion from HIV is expected for June 19.
The Lenacapavir, the drug that could send HIV global epidemic stall, is under consideration by the FDA, which should express itself on its approval on June 19th. The long -lasting antiretroviral, To be injected twice a yearhas shown to prevent the totality of the new HIV infections in the Soronegative people (i.e. exempt from viruses) to high risk of infection. The opinion of the FDA will be important not only for the use of the drug in the United States: it is a decision that will have repercussions all over the world. Let’s see why.
Lenacapavir: what it is and how it acts against HIV
Lanacapavir is an antiretroviral drug already approved and used for the treatment of patients with multiresist HIV to other available treatments. It is an antiretroviral that interferes with the formation of the capside, the “shell” that protects the genetic material of the virus, blocking various phases of viral replication. In recent months, new important studies – we wrote here – They showed a total effectiveness of the medicine also in pre-exposure prophylaxis (pre-Exposure ProphylaxisPrep), the intake of anti-hiv drugs by HIV-NEGATIVE people, who have an important risk of contracting HIV.
The intake of the same antiretroviral drugs used for the care of HIV -positive people prevents the HIV virus from replicating and establishing an infection in an organism not yet besieged by the pathogen. In recent decades, this mode has contributed strongly to curbing the HIV epidemic: however, the prep is currently based above all on the intake of oral drugs to be ingested dailywith the high risk of forgetfulness, of poor availability for those who live away from healthcare structures or occasional intake for reasons of social stigma related to the disease.
Two injections per year to prevent HIV
Injectable pre-exposure drugs would allow to solve these difficulties. Before the Lenacapavir, the longest -lasting prepa covered a couple of months. The Lenacapavir, produced by the Gilead pharmaceutical company, is injecting every six months. Its total coverage is linked to the greater adherence to therapy. For the repercussions that this could have on the reduction of the circulation of the virus and global health, the discovery of the drug had recently been awarded the recognition of “Breakthrough of the Year”, which the magazine Science reserves for the most revolutionary scientific innovations.
Lenacapavir: the examination of the FDA
As the Agency explains ReutersLenacapavir is one of the highest profile drugs to face an FDA review since the Trump government (with the discussed minister Robert F. Kennedy Jr. to Health) began his second term.
Currently, in the USA over 400,000 people use oral drugs daily to prevent HIV.
The Gilead company aims to expand the users of users to one million within the next decade, considering the greater availability of people at risk to undergo a therapy that provides only two injections per year. To reach the bands most at risk of contagion of the population, often not covered by private insurance, it will be necessary that the drug has passed by Medicaidthe US government program that provides health coverage of the less well -off bands.
Lenacapavir: agreements with developing countries
In the case of the green light of the FDA and if the WHO should follow on the wheel, recommending the use of the drug, the Lenacapavir could be marketed from the beginning of 2026 e reach at least 2 million people in 18 low income countries With a high incidence of HIV to which the Gilead has given registration priorities, granting six pharmaceutical companies of Asia and North Africa to produce a generic version of the drug at reduced costs. It is estimated that every year they contract the HIV approximately 1.3 million people in the world (WHO 2023 data).
Lanacapavir treatment for patients with multiresista HIV costs $ 42,250 per person per year in the USA. It is not clear what the price of the medicine used as a prep will be, but a study by the University of Liverpool has shown that it could be sold for 40 dollars a year per patient and still allow a large profit margin, if purchased by many people.
In total, and including the 18 with access priorities, 120 low -income countries will benefit generic versions of the drug, but the process will take time and is partly linked to the mediation of the US President’s Emergency Plan for Aids Relief (Pepfar), an American government initiative to stem the global HIV and AIDS epidemic ended up under the axis of the tagli in research. from the current administration. An important piece of world public health decides in the next few days.
