The Food and Drug Administration approves Bixlenvo, a once-daily HIV pill from Gilead Sciences for patients with suppressed viruses.
The Food and Drug Administration approved Bixlenvo, a once-daily HIV pill from Gilead Sciences, to simplify treatment for patients whose virus is already under control. The new medication combines bictegravir and lenacapavir, offering a single-tablet regimen for adults who may have struggled with complex, multi-pill schedules due to drug resistance or side effects. Jared Baeten, the clinical development and virology therapeutic area head at Gilead Sciences, stated that the pill fulfills an unmet need for patients who would not otherwise consolidate their treatment. The drug is particularly beneficial for older patients with long treatment histories who may have taken multiple pills daily. Bixlenvo is priced at $4,595 for a 30-day supply, with various assistance programs available for patients without insurance or with private coverage. The approval is based on Phase 3 trials showing that Bixlenvo maintained viral suppression at rates comparable to previous regimens while being well-tolerated by participants.