What is the interest of Yeytuo when PREP is an already available tool?
Two Yeytuo tablets are necessary the first two days of treatment, then, it should only be injected twice a year, in subcutaneous injection. “The adoption and observance of treatment are often sub-optimal, as access to certain drugs is limited and other available drugs require strict daily intake, Note the EMA in a press release. This means that many people at risk in the EU and in the world do not benefit from existing PREP options, which highlights the urgency of developing new prep methods. ”
How does Lenacapavir work?
The Lenacapavir contained in Yeytu is linked to the proteins surrounding the genetic material of the virus, the capside, interfering in several stages of the virus life cycle and inhibiting its replication. It thus helps prevent HIV infection.
Yeytuo benefited from the accelerated EMA procedure because it presents “A major public health interest in the EU and the world”. It has also been examined as part of the “Drugs for all” program (EU-M4all), evaluating drugs for countries where regulatory capacities are sometimes limited. National authorities can then rely on this scientific assessment to decide to use the drug in their country.
“A powerful tool”
In mid-July, the World Health Organization (WHO) has also recommended the use of injectable Lenacapavir (LEN). “Requiring only two doses per year, the LEN represents a decisive advance in the protection of people exposed to the risk of HIV infection, in particular those who have trouble joining daily treatment, which are victims of stigma or which are confronted with difficulties of access to health care”wrote the organization in a press release published on July 14.
“The development of an HIV vaccine remains an uncertain quest, but the Lénacapavir is what is closest to the extent that it is a prolonged action antiretroviral which has been demonstrated, in clinical trials, that it prevents almost all HIV infections in people at risk”, said the Dr Tedros Adhanom Ghebreyesus, Directeur Général de l’ames. The publication of the new WHO guidelines, combined with recent drug approval by the FDA, marks a crucial step towards expanding access to this powerful tool. The WHO undertakes to collaborate with countries and partners so that this innovation is made available to communities as quickly and as surely as possible. »»
1.3 million contaminated people worldwide in 2024
According to the WHO, in 2024, 1.3 million people were newly infected with HIV worldwide, including 160,000 in Europe and 650,000 in Africa, the region most affected by HIV. The level of contamination remained particularly high in the population at risk, sex workers, men having sex with men, transgender people, injectable drug consumers, imprisoned people, children and adolescents. “This drug could be the decisive tool to control new infections, but only if it is offered at an affordable price and accessible to all those who could benefit from it”, underlines Winnie ByANYIMA, Director General of UNUSI, quoted by AIDES.
In order to be marketed in the EU, Yeytuo must still be approved by the European Commission. In France, the High Authority for Health will then have to give the green light.
