Twice-yearly lenacapavir PrEP could be available as early as this summer pending federal Food and Drug Administration approval, with a decision expected in mid-June, Gilead Sciences Inc. announced Tuesday. Preparations for the U.S. launch are "well underway," according to Gilead chief commercial officer Johanna Mercier.
"Today, we are one step closer to introducing the first-ever twice-yearly HIV prevention choice that could, if approved, help transform the landscape for individuals who need or want additional prevention options that better fit into their lives," Gilead Chief Medical Officer Dr. Dietmar Berger stated in a news release. "We're excited about the potential of lenacapavir to make a real difference in HIV prevention in the U.S. and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere."
Lenacapavir is an HIV capsid inhibitor with a long half-life in the body, meaning it can be administered once every six months. Phase 3 studies showed that it dramatically reduced HIV acquisition in groups at high risk. Lenacapavir is an antiretroviral drug that blocks HIV replication. It's not a vaccine that trains the immune system to fight the virus. All traditional vaccine candidates tested so far have failed, so long-acting PrEP is the next best thing. Currently, ViiV Healthcare's Apretude (injectable cabotegravir), which is administered every other month, is the longest-acting approved PrEP option.
As the Bay Area Reporter previously reported, the PURPOSE 1 trial, first presented at the 2024 International AIDS Conference, showed that lenacapavir injections every six months were 100% effective for young cisgender women in Africa. The injections significantly reduced HIV incidence compared with the background rate and were superior to daily Truvada pills (tenofovir disoproxil fumarate/emtricitabine). Several studies have found that injectable antiretrovirals can encourage better adherence among women.
Likewise, the PURPOSE 2 study, presented at the HIV Research for Prevention Conference last October, showed that twice-yearly lenacapavir injections reduced the risk of HIV acquisition by 96% relative to the background incidence and by 89% compared to Truvada for gay and bisexual men and gender-diverse people in the United States and six other countries. In both trials, lenacapavir was safe and generally well-tolerated.
Two smaller Phase 2 studies are now evaluating lenacapavir and Truvada PrEP for cisgender women (PURPOSE 3) and people who inject drugs (PURPOSE 4) in the United States, while PURPOSE 5 is testing the two PrEP options in France and the United Kingdom.
Data from the pivotal PURPOSE 1 and PURPOSE 2 trials is enough for FDA approval. On December 19, Gilead announced that it had completed New Drug Application submissions for lenacapavir PrEP. It was granted an FDA Breakthrough Therapy designation and Priority Review status, intended to speed up regulatory review of investigational medications for serious or life-threatening conditions that have the potential to "demonstrate substantial improvement over available therapy." Lenacapavir (sold as Sunlenca) is currently only approved as part of a treatment regimen for people with multidrug-resistant HIV.
Under the Prescription Drug User Fee Act, or PDUFA, expedited therapies can be approved as soon as six months after an NDA submission, which puts the PDUFA target action date for lenacapavir PrEP on June 19. However, it is possible that the process could take longer. Such strong data usually bodes well for prompt review and approval, but it is unclear how FDA reorganization and staff layoffs under the Trump administration could affect the timeline.
The FDA is under the Department of Health and Human Services, which is now run by Secretary Robert F. Kennedy Jr., who in the past has repeated the falsehood that HIV doesn't cause AIDS. More recently, he has said that he supports PEPFAR, the President's Emergency Plan for AIDS Relief, which provides HIV/AIDS medication and other services to countries around the world, mostly in Africa. The status of PEPFAR is in doubt since President Donald Trump initiated a foreign aid freeze that is the subject of litigation. PEPFAR was granted a waiver to continue its programs but much confusion remains.
Gilead aims to roll out lenacapavir PrEP in the United States this summer and in Europe later in the year. But to have a real impact on the HIV epidemic, advocates and global health officials stress that long-acting PrEP must be widely available and affordable to those who need it most worldwide.
Gilead has also submitted a European Union-Medicines for All application, whereby the European Medicines Agency collaborates with the World Health Organization to speed up authorization in countries outside Europe. The company announced last year that it will work with pharmaceutical manufacturers to offer generic versions of lenacapavir PrEP in more than 100 resource-limited countries with high HIV incidence.
At an investors meeting late last year, Gilead revealed that it is working on even longer-acting injectable formulations of lenacapavir that could potentially be administered just once a year. Phase 3 trials are expected to begin soon, and data could be available for FDA review in 2027, according to Dr. Moupali Das, Gilead's vice president of clinical development for HIV prevention and pediatrics.
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