Lenacapavir, a twice-yearly HIV prevention candidate from Gilead Sciences, has demonstrated promising results in a phase 1 trial as a once-yearly dosing regimen. The intramuscular formulation, which delivered the same amount of medication as a subcutaneous injection but via injection, showed blood concentrations exceeding those achieved by the twice-yearly subcutaneous option.
Researchers administered two formulations of lenacapavir to 20 individuals each over one year, with median blood concentrations reaching 57 ng/mL and 65.5 ng/mL at the end of the study period. These levels exceeded those recorded in phase 3 preexposure prophylaxis studies for twice-yearly lenacapavir.
Gilead plans to initiate a phase 3 program for once-yearly lenacapavir later this year, with potential regulatory filings by 2027. The company aims to expand access to the HIV prevention treatment option, particularly among those seeking longer dosing intervals.
The intramuscular formulation showed favorable safety and tolerability profiles, with no grade 4 adverse events recorded. While injection-site pain was common, it remained mild and manageable with pretreatment.
Gilead’s decision on the clinical dose for future development is expected to be lower than previously anticipated due to higher-than-expected Ctrough measurements. The company will rely on extensive pharmacology data to select a dose for phase 3 testing.
The upcoming trial may also consider alternative endpoints, such as pharmacological targets rather than traditional efficacy measures like infection rates.
Source: https://www.fiercepharma.com/pharma/once-yearly-prep-gilead-lenacapavir-shows-promise-hiv-prevention-phase-3