FDA approved Gilead's new once-daily HIV pill for patients on complex regimens

Free daily briefing on global business news.

Bixlenvo combines two existing Gilead drugs into a single tablet for adults whose virus is suppressed but who can't use current one-pill options

Gilead $GILD Sciences announced Thursday that the U.S. Food and Drug Administration approved Bixlenvo, a once-daily single-tablet HIV treatment combining bictegravir and lenacapavir, for adults whose virus is already suppressed, including those on complex multi-pill regimens who cannot use existing one-tablet options.

Bixlenvo pairs bictegravir — the active ingredient in Gilead's existing HIV treatment Biktarvy — with lenacapavir, a capsid inhibitor with no cross-resistance to other antiretrovirals. The two drugs target multiple stages of the HIV life cycle through different mechanisms, the company said.

Gilead said the pill represents the first time virologically suppressed adults who cannot take any existing one-tablet option have had a single-tablet regimen to turn to. That population accounts for an estimated 5% or more of people in the U.S. living with HIV, the company told CNBC.

At $4,595 for a 30-day supply, the drug's sticker price is consistent with what other daily single-tablet HIV treatments cost, according to CNBC. The company said uninsured patients may be able to obtain the drug at no charge through its patient assistance program, and that a separate savings program could reduce out-of-pocket costs for those covered by commercial or private insurance.

The FDA approval is based on two Phase 3 trials, ARTISTRY-1 and ARTISTRY-2, in which Bixlenvo maintained viral suppression at rates comparable to patients' prior regimens at 48 weeks and was generally well tolerated, the company said. Headache, nausea, and diarrhea were the side effects most frequently reported, each occurring in at least 2% of participants.

ARTISTRY-1 enrolled patients with long treatment histories and significant drug resistance. Participants had a median age of 60 years and were taking between two and 11 pills per day before the trial, with approximately 40% taking antiretroviral therapy more than once daily. The median treatment duration among participants was 28 years, and 67% had resistance to nucleoside reverse transcriptase inhibitors. Switching to Bixlenvo was associated with improvements in certain fasting lipid levels and participant-reported treatment satisfaction, the company said.

Bixlenvo requires a two-day initiation period in which patients also take Sunlenca, another Gilead lenacapavir product, before continuing with Bixlenvo alone once daily.

Gilead Chief Executive Officer Daniel O'Day said in a statement that the approval "could be the first of many in the years ahead," pointing to a pipeline of daily, weekly, and longer-acting HIV treatment options the company is developing.

The combination of bictegravir and lenacapavir has not been approved by any regulatory authority outside the United States, the company said. There is no cure for HIV or AIDS.

Join 500,000+ readers who start their day with Quartz.

By subscribing, you agree to our Terms of Service and Privacy Policy.

Global business news for a smarter world