Gilead poised to bring twice-yearly HIV PrEP to EU
Transmission electron micrograph of HIV-1 virus particles replicating from an HIV-infected T-cell.
The EU has given Gilead the green light to market its twice-yearly pre-exposure prophylaxis (PrEP) product lenacapavir, which is viewed as a key part of the drugmaker's growth strategy in HIV.
The first-in-class capsid inhibitor will be marketed in the EU under the Yeytuo brand name and used to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV acquisition risk who weigh at least 35kg.
It was approved in the US as Yeztugo in June, but Gilead's hopes for the product suffered a setback earlier this month when US pharmacy benefit manager (PBM) CVS Health declined to cover the product on its approved formularies – at least for now – due to its high list price of more than $28,000 per year.
As usual, the pricing of Yeytuo in the EU will depend on reimbursement negotiations with reimbursement authorities in member states.
Gilead's HIV business had a tricky start to the year, reporting worse-than-expected sales in the first quarter, due to changes to Medicare Part D, but picked up in the second due to what the company said was increased demand and higher average realised prices.
It has been looking to Yeztugo/Yeytuo to restore sales momentum to historical levels, and some analysts have predicted that the drug could eventually become a $4.5 billion blockbuster.
Gilead got some good news for the global rollout of the drug in July when the World Health Organization (WHO) included the drug in its HIV prevention guidelines, paving the way for it to be used in countries around the world.
Providing two six-monthly injections should be less demanding on health resources than the current daily oral PrEP formulations and shorter-acting injectables like ViiV Healthcare's Apretude (cabotegravir) – which needs to be dosed every two months – and help to reduce the risk of missed doses that could lead to breakthrough infections.
"With around 25,000 new HIV diagnoses in the EU and European Economic Area every year, it's clear that current prevention options are not working for everyone who needs or wants them, especially among vulnerable populations," commented infectious disease specialist Jean-Michel Molina of Université Paris Cité and the Saint-Louis and Lariboisière Hospitals in France.
"Yeytuo's novel twice-yearly dosing schedule and high efficacy could be the transformative HIV prevention option in Europe we've been waiting for to help us reduce new infections and make real progress toward ending the HIV epidemic," he added.
Gilead said it has also filed twice-yearly lenacapavir in Australia, Brazil, Canada, South Africa, and Switzerland, and is preparing filings in Argentina, Mexico, and Peru.
In a bid to expand access, Gilead signed an agreement in July with the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) to supply enough doses of lenacapavir to two million people over three years – on a non-profit basis – to low- and lower-middle-income countries (LLMICs).
According to the WHO, 1.3 million people acquired HIV in 2024, the same number as in the previous year, highlighting the continued need for new PrEP options. In trials, Yeztugo/Yeytuo was 100% effective at preventing HIV transmission.
Photo by National Institute of Allergy and Infectious Diseases on Unsplash
