FDA sets date for decision on twice-yearly shots to prevent HIV
Key takeaways:
- Lenacapavir is delivered in subcutaneous injections given every 6 months.
- In two phase 3 trials, it was shown to reduce the risk for HIV infection by 96% to 100%.
The FDA has accepted Gilead Sciences’ new drug application for lenacapavir as a long-lasting injectable to prevent HIV infection and set a date of June 19 to decide on its approval, Gilead announced Tuesday.
Delivered in two subcutaneous injections every 6 months, lenacapavir received breakthrough therapy designation from the FDA in October after it was shown to reduce the risk for HIV infection by 100% in a phase 3 trial of cisgender adolescent girls and young women in Africa, and by 96% in a phase 3 trial of gender-diverse participants in seven countries, including the United States. It also demonstrated superiority over Gilead’s daily oral PrEP medication, emtricitabine/tenofovir disoproxil fumarate.
The capsid inhibitor is already approved in the U.S. for the treatment of resistant HIV infections. If approved for HIV prevention, it would become the second long-acting injectable PrEP option on the market after ViiV Healthcare’s cabotegravir, which is administered every 2 months.
Experts have described twice-yearly lenacapavir as a potential breakthrough in HIV prevention. Below is a timeline of some of our coverage.
Twice-yearly shot prevents HIV in phase 3 trial, Gilead reports
In June, Gilead announced topline results from an interim analysis of the PURPOSE 1 trial, which showed that lenacapavir prevented HIV acquisition among cisgender adolescent girls and young women at 28 trial sites in South Africa and Uganda. Read more.
Full results confirm potential breakthrough in HIV prevention
In July, full results of PURPOSE 1 were published in The New England Journal of Medicine and presented at a major scientific meeting, the International AIDS Conference in Munich. In a perspective, Healio | Infectious Disease News Chief Medical Editor Paul A. Volberding, MD, called the results, “a dramatic game-changer in the crucial issue of HIV prevention.” Read more.
Twice-yearly injections prevent HIV in another phase 3 trial
Results from the PURPOSE 2 trial were shared by Gilead in September, showing that lenacapavir reduced HIV infections by 96% compared with background HIV incidence among cisgender men, transgender men, transgender women and gender nonbinary people who have sex with men, and demonstrated superiority over daily oral PrEP. Read more.
Lenacapavir poised to ‘transform’ HIV prevention
Positive findings from the lenacapavir trials continued to roll in at the HIV Research for Prevention conference in Lima, Peru. “Lenacapavir for PrEP has the potential to transform — together with other agents — the global HIV prevention landscape for people of all genders,” said International AIDS Society President Beatriz Grinsztejn, MD, PhD. Read more.
Does the world still need an HIV vaccine? Experts say yes
The advent of long-acting PrEP has energized the field of HIV prevention research but also muddied the future of HIV vaccine research. For instance, how can a trial evaluate HIV vaccine efficacy if participants are also offered injections of lenacapavir for ethical reasons? We asked experts if the world still needs an HIV vaccine given the success of long-acting injectables, and they all had the same answer. This story also includes details on the potential cost of lenacapavir PrEP. Read more.
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