March 14, 2025
2 min learn
Key takeaways:
- Two formulations of once-yearly injectable lenacapavir for PrEP had been secure, nicely tolerated and generated acceptable blood ranges of the drug.
- Gilead mentioned it plans to start out part 3 trials later this yr.
SAN FRANCISCO — New knowledge recommend that lenacapavir delivered simply as soon as per yr could possibly be as efficient for HIV prevention because the twice-yearly injections already below assessment by the FDA.
Gilead Sciences introduced knowledge from a part 1 examine of once-a-year lenacapavir for HIV PrEP on the Convention on Retroviruses and Opportunistic Infections and printed the outcomes concurrently in The Lancet.
A part 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 individuals to obtain the drug simply as soon as per yr as an alternative of twice.
“What we discovered is that the … blood ranges of those formulations had been increased than twice-yearly subcutaneous lenacapavir,” Renu Singh, PhD, MS, senior director and medical pharmacologist at Gilead, advised Healio.
It means once-yearly lenacapavir “can present related ranges of excessive efficacy as we’ve seen with twice-yearly subcutaneous lenacapavir,” Singh mentioned. “Each formulations had been secure and nicely tolerated, and with these encouraging outcomes we plan to provoke part 3 research later this yr.”
Lenacapavir is already accredited to be used in america for the remedy of resistant HIV. The FDA has scheduled a June deadline to contemplate Gilead’s utility to market lenacapavir as a twice-yearly injectable for PrEP primarily based on the outcomes of two part 3 trials, PURPOSE 1 and PURPOSE 2. Specialists have heralded the drug as a possible breakthrough in HIV prevention.
In an ongoing, open-label part 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 by 15 after injection and picked up single anytime PK samples by day 449 of the trial. They measured the PK samples for optimum noticed focus and trough focus.
In accordance with Gilead’s abstract of the information, plasma concentrations for once-yearly lenacapavir “remained above the 95% efficient focus for no less than 56 weeks with each formulations,” and the median trough concentrations of each formulations after 1 yr had been increased than they had been within the two PURPOSE trials by 16 weeks.
Moreover, members within the two teams skilled related ranges and severity of antagonistic occasions, together with injection-site reactions and gentle ache.
“As a medical pharmacologist, it offers me nice pleasure to see a small molecule final this lengthy,” Singh mentioned. “It has by no means been carried out earlier than, so I’m actually thrilled about these knowledge. Total, 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. Offered at: Convention on Retroviruses and Opportunistic Infections; March 9-12, 2025; San Francisco.
Disclosures:
Singh is employed by Gilead Sciences.
