Gilead inspired by information on once-yearly lenacapavir for HIV prevention
March 14, 2025
2 min learn
Key takeaways:
- Two formulations of once-yearly injectable lenacapavir for PrEP have been protected, effectively tolerated and generated acceptable blood ranges of the drug.
- Gilead mentioned it plans to begin section 3 trials later this 12 months.
SAN FRANCISCO — New information recommend that lenacapavir delivered simply as soon as per 12 months could possibly be as efficient for HIV prevention because the twice-yearly injections already beneath assessment by the FDA.
Gilead Sciences introduced information from a section 1 examine of once-a-year lenacapavir for HIV PrEP on the Convention on Retroviruses and Opportunistic Infections and revealed the outcomes concurrently in The Lancet.
A section 1 trial discovered {that a} formulation of lenacapavir maintains blood ranges excessive sufficient for use as once-yearly injectable PrEP. Picture: Adobe Inventory
The examine confirmed that both of the 2 new formulations of the drug could possibly be efficient, permitting folks to obtain the drug simply as soon as per 12 months as a substitute of twice.
“What we discovered is that the … blood ranges of those formulations have been larger than twice-yearly subcutaneous lenacapavir,” Renu Singh, PhD, MS, senior director and scientific pharmacologist at Gilead, advised Healio.
It means once-yearly lenacapavir “can present related ranges of excessive efficacy as we now have seen with twice-yearly subcutaneous lenacapavir,” Singh mentioned. “Each formulations have been protected and effectively tolerated, and with these encouraging outcomes we plan to provoke section 3 research later this 12 months.”
Lenacapavir is already accepted to be used in america for the therapy of resistant HIV. The FDA has scheduled a June deadline to think about Gilead’s software to market lenacapavir as a twice-yearly injectable for PrEP primarily based on the outcomes of two section 3 trials, PURPOSE 1 and PURPOSE 2. Specialists have heralded the drug as a potential breakthrough in HIV prevention.
In an ongoing, open-label section 1 trial, Singh and colleagues evaluated two intramuscular formulations containing a 5,000 mg dose of lenacapavir — one containing 5% ethanol and one other containing 10% ethanol — amongst 40 adults aged 18 to 55 years assigned in a 1:1 ratio to every formulation. (Twice-yearly lenacapavir consists of 927 mg of the drug delivered in two injections each 26 weeks.)
The researchers evaluated the security and tolerability of the injections amongst members and assessed the pharmacokinetics (PK) and security from days 1 via 15 after injection and picked up single anytime PK samples via day 449 of the trial. They measured the PK samples for max noticed focus and trough focus.
In line with Gilead’s abstract of the info, plasma concentrations for once-yearly lenacapavir “remained above the 95% efficient focus for at the very least 56 weeks with each formulations,” and the median trough concentrations of each formulations after 1 12 months have been larger than they have been within the two PURPOSE trials via 16 weeks.
Moreover, members within the two teams skilled related ranges and severity of hostile occasions, together with injection-site reactions and delicate ache.
“As a scientific pharmacologist, it offers me nice pleasure to see a small molecule final this lengthy,” Singh mentioned. “It has by no means been finished earlier than, so I’m actually thrilled about these information. General, these outcomes point out that once-annual lenacapavir has the potential to supply considerably excessive efficacy.”
References:
Sources/Disclosures
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Singh R, et al. Summary 154. Introduced at: Convention on Retroviruses and Opportunistic Infections; March 9-12, 2025; San Francisco.
Disclosures:
Singh is employed by Gilead Sciences.
