GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal

Core Insights - Gilead Sciences, Inc. announced that its investigational single-tablet regimen of bictegravir and lenacapavir for HIV treatment met the primary endpoint in the ARTISTRY-2 study [1][6] Study Details - ARTISTRY-2 is a multicenter, double-blind, randomized phase III study comparing the safety and efficacy of the once-daily combination of bictegravir and lenacapavir (BIC/LEN) versus Biktarvy in virologically suppressed individuals with HIV [2] - The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at week 48, and BIC/LEN was found to be statistically non-inferior to Biktarvy [3][10] Product Information - Bictegravir is a globally recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, while lenacapavir is approved for pre-exposure prophylaxis (PrEP) and treatment of multi-drug-resistant HIV [4][5] - The single-tablet regimen combining bictegravir and lenacapavir could reshape the HIV treatment landscape by providing more options for maintaining virologic suppression [6] Market Position - Gilead has a leading HIV franchise, with Biktarvy accounting for over 52% of the treatment market in the U.S. and Descovy holding more than 45% of the U.S. PrEP market [8][9] - The approval of lenacapavir as a twice-yearly injectable option for HIV prevention enhances Gilead's portfolio, especially as it faces competition from generics [11][12] Financial Performance - Yeztugo, the brand name for lenacapavir, generated $39 million in sales in the third quarter, achieving a 75% coverage goal ahead of schedule [13] - Gilead's shares have increased by 29.7% year to date, outperforming the industry growth of 18.9% [11] Competitive Landscape - Positive data from the ARTISTRY studies is expected to strengthen Gilead's HIV franchise amid increasing competition from companies like GSK, which is expanding its HIV business with long-acting injectable medicines [14]