Gilead's Lenacapavir Shows Sustained Efficacy In Pretreated HIV Patients

Gilead Sciences Inc GILD announced new one-year results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir in heavily pretreated multi-drug resistant HIV patients.

• The findings demonstrated that lenacapavir, administered every six months in combination with other antiretrovirals, achieved high rates of virologic suppression.
• The data also showed clinically meaningful increases in CD4 counts in people living with HIV whose virus was no longer effectively responding to their current therapy. 
• Related: FDA Slaps Clinical Hold On Gilead's Injectable Lenacapavir In HIV Trials.
• 83% (n=30/36) of participants receiving lenacapavir in combination with an optimized background regimen achieved an undetectable viral load at Week 52. 
• Lenacapavir was generally well tolerated in CAPELLA, with one adverse event (AE) leading to study drug discontinuation at Week 52 and no serious adverse events related to lenacapavir. 
• The most common adverse events observed in the CAPELLA study were injection site reactions (63%), mostly mild or moderate in severity. The most common adverse events, excluding injection site reactions, were nausea and diarrhea (13% each) and COVID-19 (11%).
• Price Action: GILD shares are down 0.82% at $61.39 during the market session on the last check Thursday.