Gilead’s lenacapavir holds greater potential in reducing HIV incidence than currently marketed drugs
Gilead’s lenacapavir holds greater potential in reducing HIV incidence than currently marketed drugs
At the 25th International AIDS Conference (AIDS 2024) that took place from July 22-26 in Munich, Germany, Gilead presented full efficacy and safety results for its Phase III PURPOSE 1 HIV prevention trial for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor. Lenacapavir demonstrated zero infections and 100% efficacy, as well as superior prevention of HIV infections compared to oral pre-exposure prophylaxis (PrEP). While questions remain surrounding the accessibility of lenacapavir, the drug holds greater potential for reducing the global incidence of HIV than any other to date, says GlobalData, a leading data and analytics company.
The Phase III PURPOSE 1 trial compared lenacapavir as PrEP to daily oral PrEP among 5,345 HIV-negative, cisgender adolescent girls and young women in South Africa and Uganda.
Fiona Chisholm, Associate Director of Infectious Diseases at GlobalData, comments: “This is the first time ever that zero infections have been observed in a Phase III HIV prevention trial, making this a truly groundbreaking result. Data from a second pivotal trial, PURPOSE 2*, is also eagerly anticipated, with these results expected in late 2024/early 2025.”
Although lenacapavir is an investigational drug for PrEP, it is already approved for the treatment of multi-drug resistant HIV in various high-income countries, under the brand name Sunlenca. Key opinion leaders (KOLs) interviewed by GlobalData in 2024 reported good experiences with using lenacapavir to treat HIV-infected patients and were enthusiastic about the prospect of using the drug for PrEP. In particular, KOLs noted that lenacapavir’s long-acting formulation has the potential to improve adherence to PrEP.
Chisholm continues: “If approved, lenacapavir would be the first twice-yearly injectable PrEP agent in the global HIV market, providing an important alternative for people who struggle to adhere to daily treatment.”
However, among the countries where lenacapavir is already approved for multi-drug resistant HIV, the drug has a high price tag. For example, according to one KOL, the annual cost in Spain is approximately €44,000 ($47,000) per patient. Currently, it is unclear how lenacapavir will be priced for HIV prevention in various markets. Gilead has stated that it is too early to provide details on pricing, but it is working alongside HIV-affected communities, governments, advocates, multilateral organizations, and individuals to develop a strategy to enable broad, sustainable access globally.
Organizations such as Médecins Sans Frontières (MSF) are advocating for the company to license lenacapavir to other manufacturers through the Medicines Patent Pool, which would enable generic production in low- and middle-income countries.
Chisholm concludes: “The PURPOSE 1 trial results have deservedly generated much excitement within the HIV field. Agencies such as the FDA are likely to receive regulatory submissions for lenacapavir as PrEP within the next year. Consequently, accessibility of the drug has been a hot topic at AIDS 2024.”
*PURPOSE 2 is investigating lenacapavir for PrEP among cisgender men, transgender men, transgender women and gender non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US who have sex with partners assigned male at birth.
Source: GlobalData
