March 14, 2025
2 min learn
Key takeaways:
- Two formulations of once-yearly injectable lenacapavir for PrEP have been protected, properly tolerated and generated acceptable blood ranges of the drug.
- Gilead stated it plans to start out section 3 trials later this 12 months.
SAN FRANCISCO — New knowledge 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 evaluate by the FDA.
Gilead Sciences offered knowledge from a section 1 research 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 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 research 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 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 comparable ranges of excessive efficacy as now we have seen with twice-yearly subcutaneous lenacapavir,” Singh stated. “Each formulations have been protected and properly tolerated, and with these encouraging outcomes we plan to provoke section 3 research later this 12 months.”
Lenacapavir is already authorised to be used in the USA 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 section 3 trials, PURPOSE 1 and PURPOSE 2. Consultants 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 protection and tolerability of the injections amongst contributors and assessed the pharmacokinetics (PK) and security from days 1 by way of 15 after injection and picked up single anytime PK samples by way of day 449 of the trial. They measured the PK samples for optimum noticed focus and trough focus.
In keeping 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 12 months have been increased than they have been within the two PURPOSE trials by way of 16 weeks.
Moreover, contributors within the two teams skilled comparable ranges and severity of opposed occasions, together with injection-site reactions and delicate ache.
“As a medical pharmacologist, it offers me nice pleasure to see a small molecule final this lengthy,” Singh stated. “It has by no means been finished earlier than, so I’m actually thrilled about these knowledge. 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.
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