FDA Approves Gilead Bixlenvo Once-Daily HIV Treatment for Complex Cases

FDA approves Gilead $GILD once-daily HIV pill Bixlenvo for complex treatment cases. The list price for the single-tablet drug is $4,595 for a 30-day supply before discounts or rebates. Gilead estimates the medication targets 5% or more of US adults living with HIV who cannot use current single-pill options. The treatment combines bictegravir with lenacapavir to attack the virus using two distinct mechanisms. Phase 3 trial participants previously taking between two and 11 pills daily maintained viral suppression at 48 weeks after switching. "It fulfills an unmet need, particularly for individuals who are on complex regimens who just would not otherwise consolidate down to something really meaningful for them and prescribers." — Dr. Jared Baeten, Gilead clinical development head. Consolidating multi-pill regimens into a single daily tablet reduces dosing complexity while preserving future options for aging patients.