Key takeaways:
- Lenacapavir is the second long-acting injectable to hit the marketplace for HIV prevention.
- The capsid inhibitor is run in two pictures given twice per yr.
The FDA on Wednesday permitted a extremely efficient long-acting shot for HIV prevention that’s administered simply twice per yr, vastly extending the time folks can go between doses of a drugs that protects them from the virus.
Lenacapavir was already permitted in america as a therapy for folks with drug-resistant HIV. Now, the first-in-class capsid inhibitor may also be obtainable for HIV prevention, delivered in the identical approach it’s for therapy — in two subcutaneous injections given round each 6 months.
The drug’s producer, Gilead Sciences, introduced the approval and stated lenacapavir as PrEP will probably be branded Yeztugo. The FDA permitted it for adolescents and adults weighing at the least 35 kg, or round 77 kilos. Gilead chairman and CEO Daniel O’Day known as the approval “a historic day within the decades-long struggle towards HIV.”
It’s the second long-acting injectable to hit the marketplace for HIV prevention. The opposite, ViiV Healthcare’s cabotegravir, was permitted by the FDA in December 2021 and is run each 2 months.
Consultants have hailed lenacapavir as a probably transformative remedy for HIV prevention, able to hastening the top of the HIV epidemic if used extensively.
Though it’s an antiretroviral drug and never a vaccine, it’s maybe the closest factor to an HIV vaccine that science has ever produced, if solely in spirit, offering safety for round so long as a flu shot, to make an imperfect comparability.
A vaccine should still be thought-about the holy grail of HIV prevention, however a sequence of setbacks in main trials over the previous a number of years served as a stark reminder of how troublesome it’s to develop one. Latest cuts to HIV funding — together with for vaccine analysis — have additional strained that space of analysis.
The success of lenacapavir additionally has muddied HIV vaccine growth, sending researchers again to the drafting board to design trials that may reckon with the excessive stage of safety provided by the injectable. Any future candidate will probably be measured towards the efficiency of the twice-yearly shot, which prevented almost 100% of recent HIV infections in two section 3 randomized, managed trials. Future trials may also in all probability have to supply contributors injections of lenacapavir for moral causes, additional complicating their design.
Within the PURPOSE 1 trial, lenacapavir diminished the danger for HIV an infection by 100% amongst cisgender adolescent ladies and younger ladies in Africa. It was equally efficient in PURPOSE 2, lowering HIV infections by 96% amongst gender-diverse contributors in seven nations, together with the U.S. There are different PURPOSE trials underway to evaluate lenacapavir PrEP in much more populations, together with individuals who inject medicine.
Lenacapavir additionally demonstrated superiority over Gilead’s day by day oral PrEP tablet, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), though that remedy and different variations of HIV PrEP have all been proven to stop HIV at excessive ranges.
In response to Mitchell Warren, govt director of the nonprofit AVAC, which focuses on HIV prevention, lenacapavir had the quickest journey to approval of any HIV prevention remedy. Warren known as the approval “a much-needed increase for HIV prevention, given the power of the science and the simultaneous disruption in HIV applications globally” however stated there are nonetheless hurdles to beat earlier than it can have an effect on lowering the 1.3 million new HIV infections that happen every year.
Traditionally, new HIV medicines have arrived with questions on price and entry, and lenacapavir is not any completely different in that regard. As therapy for extremely resistant HIV, it prices greater than $42,000 per yr within the U.S. The checklist value for PrEP will probably be $28,218, in accordance with a Gilead spokesperson, who stated the corporate “expects to see broad insurance coverage protection.” By way of increasing entry, the corporate signed royalty-free agreements with six pharmaceutical firms final yr that may permit them to make generic variations of lenacapavir for 120 nations with a excessive incidence of HIV however restricted assets. The plan will prioritize 18 nations that account for round 70% of recent infections, Gilead stated.
Warren stated Gilead ought to launch lenacapavir PrEP at a value that’s corresponding to the value of generic FTC/TDF — one thing that isn’t anticipated to occur immediately, he stated, however might be facilitated by funders buying giant volumes of the drug from Gilead and a number of generic producers, driving down the worth.
“Scientific progress solely issues if innovation really reaches folks,” Warren instructed Healio.
References:
- Bekker LG, et al. Summary SS0407. Offered at: AIDS 2024; July 22-26, 2024; Munich.
- Bekker LG, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2407001.
- Gilead indicators royalty-free voluntary licensing agreements with six generic producers to extend entry to lenacapavir for HIV prevention in high-incidence, resource-limited nations. https://www.gilead.com/information/news-details/2024/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries. Printed Oct. 2, 2024. Accessed June 18, 2025.
- Gilead’s twice-yearly lenacapavir for HIV prevention reduces HIV infections by 96% and demonstrated superiority to day by day Truvada in second pivotal section 3 trial. https://www.gilead.com/information/news-details/2024/gileads-twice-yearly-lenacapavir-for-hiv-prevention-reduced-hiv-infections-by-96-and-demonstrated-superiority-to-daily-truvada-in-second-pivotal-phase-3-trial. Printed Sept. 12, 2024. Accessed June 18, 2025.
- World Fund, PEPFAR announce coordinated effort to achieve 2 million folks with lenacapavir for PrEP to considerably scale back international HIV infections. https://www.theglobalfund.org/en/information/2024/2024-12-17-global-fund-pepfar-coordinated-effort-2-million-people-lenacapavir-prep/. Printed Dec. 17, 2024. Accessed June 18, 2025.
- Yeztugo (lenacapavir) is now the primary and solely FDA-approved HIV prevention possibility providing 6 months of safety. https://www.gilead.com/information/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection. Printed June 18, 2025. Accessed June 18, 2025.
For extra data:
Mitchell Warren will be reached at mitchell@avac.org.
Perspective
Though HIV vaccine growth has confronted sturdy headwinds, stopping transmission and HIV acquisition have made large progress. Viral suppression by means of potent therapy is now anticipated and may virtually utterly block unfold. And the usage of antiretroviral medicine in uninfected people in danger for HIV as PrEP additionally has made nice progress. Every day oral PrEP is efficient, primarily restricted solely by one’s capacity to stick to taking tablets as directed. Extra not too long ago, PrEP has been improved with the choice of much less frequent drug supply by means of injection of long-acting formulations.
In a game-changing new growth, PrEP within the type of a really potent drug, lenacapavir, given each 6 months has been permitted after proving virtually 100% efficient in stopping HIV an infection in very giant worldwide medical trials. Unintended effects have been minimal, largely delicate ache on the injection web site. The mixture of really efficient therapy and really long-acting PrEP injections now give us outstanding instruments to finish the HIV epidemic. Efforts should now be prolonged by means of implementation analysis and coverage formation to supply these remodeling breakthroughs nationally and internationally to the hundreds of thousands who stand to profit. Many lives will be saved if we’ve got the desire to succeed.
Paul A. Volberding, MD
Chief Medical Editor, Healio | Infectious Illness Information
Professor emeritus of drugs, College of California, San Francisco
Disclosures: Volberding studies being chair of the impartial information monitoring committee for the PURPOSE 1 and a couple of trials supported by Gilead.
