US FDA Approves Gilead's Once-Daily HIV Pill Bixlenvo at $4,595 per 30-Day Course

The US Food and Drug Administration on August 27 approved Gilead's once-daily oral HIV drug Bixlenvo. The medication is intended for patients whose virus is already suppressed but who require complex treatment regimens, and it also serves as an alternative for those seeking to switch therapies. Bixlenvo is a single-tablet combination containing bictegravir and lenacapavir. Bictegravir is a key component of Gilead's best-selling HIV drug Biktarvy, while lenacapavir is a first-in-class capsid inhibitor and a core element of the company's long-term strategy for HIV treatment and prevention. Gilead said this is the first single-tablet regimen approved for adults with HIV who are virologically suppressed and unable to use existing single-tablet options, a group representing at least 5% of HIV patients in the United States.

The drug's undiscounted list price is $4,595 for a 30-day course, comparable to other existing once-daily HIV treatments. Uninsured patients can receive Bixlenvo free through Gilead's patient assistance program, while those with commercial or private insurance may receive copay support through a separate savings program. There is currently no cure for HIV, and many infected individuals manage the disease with once-daily single tablets, a treatment approach Gilead pioneered two decades ago. However, some patients cannot use existing single-tablet regimens due to resistance, side effects, or drug interactions, and they must take multiple pills daily with complex dosing schedules.

The approval was based on two Phase 3 clinical trials evaluating Bixlenvo in adults with HIV who were virologically suppressed during treatment, including patients switched from Biktarvy or complex multi-tablet regimens. The ARTISTRY-1 trial specifically enrolled patients with long treatment histories and drug resistance, many of whom were taking multiple HIV medications daily before switching. Participants had a median age of 60 years and took between 2 and 11 pills per day. Both trials showed that viral suppression at 48 weeks was comparable to patients' prior regimens, with good overall tolerability and no new safety concerns. The most commonly reported side effects were headache, nausea, and diarrhea, occurring in at least 2% of participants.

Timothy Cameron, a 64-year-old retired Seattle resident who has lived with HIV for over 40 years, was a participant in ARTISTRY-1. When he was first diagnosed, few treatment options were available, and over the years he tried multiple HIV drugs and experimental regimens, leading to drug resistance. Before joining the study, his control regimen required taking one HIV pill twice daily along with another medication. After switching to Bixlenvo, his virus remained suppressed with no side effects, and his daily pill count and variety were reduced. This two-drug regimen controlled the virus while decreasing the number of medications he took.