Is an HIV Vaccine Still Needed in the Era of Twice-Yearly Lenacapavir?
- FHS Coomunications, Glenda Gray
Experts say yes
Study overview
In November 2024, results from two large clinical trials, PURPOSE 1 and PURPOSE 2, showed that lenacapavir, a long-acting injectable drug, offers extremely high protection against HIV. PURPOSE 2 focused on cisgender men and gender-diverse individuals, while PURPOSE 1 focused on cisgender women.
Lenacapavir is given just twice a year and is thermostable, meaning it does not need refrigeration, which makes it more practical to distribute globally.
However, while the drug is very promising, experts warn that it cannot be the only tool used to fight the HIV pandemic. PrEP with lenacapavir needs to be repeated every six months, which depends on individuals having regular healthcare access and recognising their risk. In places with fragile health systems or during times of crisis, this can be a major barrier.
There are also concerns about equity. Current PrEP programmes often miss people who do not fit the typical "high-risk" profile but who still contract HIV. In addition, if adherence to PrEP is inconsistent, there is a risk of drug resistance.
Key findings
Twice-yearly injectable PrEP using lenacapavir has shown almost complete protection against HIV infection in clinical trials. This represents a major breakthrough in HIV prevention.
But researchers and experts believe that an HIV vaccine is still urgently needed to fully end the global epidemic. Vaccines provide long-term protection, do not rely on individuals remembering to seek treatment, and can be rolled out to large populations through public health systems.
While lenacapavir is a game-changer, it is not enough on its own. Experts say a multi-pronged strategy that includes both long-acting PrEP and an effective vaccine will be key to ending HIV once and for all
Original Article In: New England Journal of Medicine
In a separate commentary published in the New England Journal of Medicine, Professors Gray and Francois Venter write that nearly 15 years after the findings of the Preexposure Prophylaxis Initiative (iPrEx) experiment were published PrEP is only given to 15% of those who would benefit from it.
They warn that the recent moderate decline in the global incidence of HIV infection takes the urgency away from the persistently high rates of infection in high-, middle-, and low-income countries, particularly among young women in southern Africa.