Gilead seeks FDA approval for lenacapavir, a long-acting HIV treatment
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Gilead Sciences submitted a new drug application to the FDA for the approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor that is given subcutaneously every 6 months.
Lenacapavir is for heavily treatment-experienced patients with multidrug-resistant (MDR) HIV. The application is supported by data from a phase 2/3 trial that evaluated the safety and efficacy of lenacapavir in combination with an optimized background regimen.
An FDA approval would make lenacapavir the first capsid inhibitor and only HIV-1 treatment option that is given every 6 months, Gilead noted.
“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multidrug-resistant HIV who have very limited treatment options,” Gilead Chief Medical Officer Merdad Parsey, MD, PhD, said in a news release. “The ling moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multidrug-resistant HIV.”
Lenacapavir has been developed for adult and pediatric patients weighing at least 35 kg with MDR HIV-1 infections who are currently on failing ART regimens.
Key data for lenacapavir will be presented during the International AIDS Society (IAS) Conference this month, Gilead said.
Perspective
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Treating MDR HIV continues to be a challenge, and we need new drugs with new mechanisms of action to win this battle. As the first capsid inhibitor, lenacapavir has the potential to fit nicely into this niche. In addition, it is delivered by subcutaneous injection, meaning that it could actually be self-administered by patients, and it has a very long half-life that supports dosing every 6 months.
The preliminary data in 36 patients presented at CROI 2021 were encouraging in terms of viral suppression, and it is good news that 6-month follow-up data will be presented at the July IAS conference. As always, when announcements are made by press release, we must wait for the data. And we absolutely must have longer term data beyond 6 months in a larger number of patients, especially when we are talking about a long-acting medication. One concern is that early studies have shown some emergence of capsid mutations.
To minimize the risk of resistance, it will be very important to pair lenacapavir with robust partners. Ideally, these partners should be long acting to take advantage of that quality. Islatravir, an investigational long-acting nucleotide reverse transcriptase translocation inhibitor, could be a great partner for lenacapavir, and Merck and Gilead are already collaborating to explore this combination. Lenacapavir with appropriate partners also could be attractive for early treatment, and it is being explored as a solo drug for prevention.
Today’s pipeline of HIV treatments have a high bar to meet because they must be potent, safe, tolerable, easy to administer, forgiving in the setting of nonadherence, and — increasingly — they must be affordable. If Gilead receives approval for lenacapavir, I hope it will set the bar low for price, thus really becoming the game-changer that it has the potential to be.
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