Eyes on HIV Prevention

Lenacapavir from Gilead Sciences has shown promise when dosed even more widely apart, only once a year, after making waves with outstanding trial results as a twice-yearly HIV prevention option. In preexposure prophylaxis (PrEP) trials, two distinct once-yearly formulations of lenacapavir demonstrated blood concentrations that were higher than those linked to the potent HIV prevention efficacy demonstrated by twice-yearly lenacapavir.

Gilead intends to launch a phase 3 study for once-yearly lenacapavir in the second half of this year, with the possibility of regulatory filings in 2027, based on the preliminary data.The FDA is presently reviewing Gilead's application for twice-yearly lenacapavir as a PrEP alternative on a priority basis, and a decision is anticipated by June 19th. Under the brand name Sunlenca, the medication is already authorised for use in conjunction with other antivirals to treat HIV infections that are resistant to several drugs. Twice-yearly lenacapavir is provided as 927 mg subcutaneous injections every six months. Gilead researchers studied two intramuscular formulations of lenacapavir in a 5g dose for the annual study. The formulations were made with either 5% or 10% ethanol, which reduces the injection's thickness.

The two once-yearly formulations were administered to groups of 20 participants each in the phase 1 trial. The median blood levels of lenacapavir at the one-year point was 65.5 ng/mL and 57 ng/mL, respectively. Samples from the phase 3 Purpose 1 and Purpose 2 investigations were analysed, and both exceeded the 23.4 ng/mL measured by twice-yearly subcutaneous lenacapavir at the end of 26 weeks.

For the two formulations, peak lenacapavir concentrations were attained after a median of almost 12 weeks or 10 weeks, respectively. Following a gradual, usually stable decline, their levels stayed higher than subcutaneous lenacapavir for the remainder of the research. Both formulations were well tolerated in terms of safety, and no grade 4 treatment-emergent adverse events were noted.

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