Gilead Sciences receives FDA approval for Bixlenvo HIV treatment

The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ Bixlenvo, a once-daily single-pill HIV treatment. The medication combines bictegravir and lenacapavir, targeting adult HIV patients who have suppressed viral loads but cannot use existing single-tablet options or wish to transition from Biktarvy.

Bixlenvo is designed to assist patients who have developed drug resistance or require complex multi-drug regimens, some of whom were taking between two and 11 pills daily. Clinical trials (ARTISTRY-1 and ARTISTRY-2) demonstrated that the combination maintained viral suppression through 48 weeks, comparable to existing therapies. Common side effects reported included headache, nausea, and diarrhea.

The 30-day supply of Bixlenvo has a list price of $4,595. Gilead noted that the drug is intended to expand treatment options rather than directly replace its flagship product, Biktarvy. The approval marks a significant step for patients with long-term treatment histories, including those with a median treatment duration of 28 years.