GILD Data on Once-Yearly Lenacapavir for HIV Prevention Positive

Core Viewpoint - Gilead Sciences, Inc. announced positive data from its phase I study of lenacapavir, a once-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP) [1][2][4] Group 1: Study Results - The phase I study evaluated the pharmacokinetics, safety, and tolerability of two intramuscular single-dose 5000mg lenacapavir formulations, involving 40 healthy adults aged 18 to 55 [3][6] - The study demonstrated that both formulations achieved and maintained plasma concentrations exceeding those associated with HIV prevention efficacy observed in late-stage studies [4][5] - The most commonly reported adverse event was injection site pain, which was alleviated by pretreatment with an ice pack, with medication-emergent adverse events being mostly mild to moderate [6] Group 2: Market Position and Future Plans - Gilead's shares have increased by 56.8% over the past year, contrasting with an 8.6% decline in the industry [2] - The company plans to initiate a phase III study for once-yearly lenacapavir in the second half of 2025 [4] - Lenacapavir is already approved in multiple countries for treating adults with multi-drug resistant HIV, and its potential approval for PrEP could further solidify Gilead's position in the HIV market [8][10] Group 3: Competitive Landscape - Gilead's Biktarvy remains the top prescribed regimen for both treatment-naïve and switch patients, maintaining a strong market share [8][10] - The approval of lenacapavir would enhance Gilead's competitive edge, as it requires administration only twice yearly compared to daily oral medications [10] - The HIV treatment landscape is becoming increasingly competitive, with GSK reporting a 13% growth in HIV sales in 2024, driven by demand for long-acting injectable medicines [12][13]