Some 20 years after helping introduce the first once-daily single tablet HIV regimen, Gilead Sciences has crossed the regulatory finish line with a new oral treatment option in the U.S.
The FDA approval of Bixlenvo tees up a new HIV treatment option for virologically suppressed adults, including those on complex drug regimens for whom other single tablet options are a poor match. The daily tablet weds the tried-and-true integrase strand transfer inhibitor bictegravir with Gilead’s more recent capsid inhibitor lenacapavir.
The tablet marks a fusion of two eras of Gilead’s history. Bictegravir is one of three ingredients in current HIV standard-of-care Biktarvy, which has defined much of Gilead’s recent trajectory combatting the virus. For its part, lenacapavir—first approved as Sunlenca as part of an HIV treatment option in 2022 and then as Yeztugo as a twice-yearly PrEP injection last summer—signals where the company is headed next with its HIV franchise.
In a statement Thursday, Gilead CEO Daniel O’Day framed the approval as meaningful to those HIV patients wanting to switch up or simplify their treatment.
“Our goal at Gilead is to provide multiple options for HIV treatment and prevention,” he said.
The green light was backed up by data from Gilead’s late-stage Artistry-1 and -2 studies, which sought to enroll a broad spectrum of people living with HIV.
Artistry-1 specifically looked at Bixlenvo in patients presently managing their HIV with complex multi-tablet regimens, due to factors like acquired drug resistance, tolerance issues or drug interactions. Artistry-2, on the other hand, pitted Gilead’s new doublet pill against its own Biktarvy, where it proved non-inferior in maintaining virologic suppression in patients who switched.
In both studies, the percentage of patients with HIV-1 RNA levels ≥50 copies/mL—a standard measure of detectable HIV—at week 48 was used as the primary endpoint.
Patients who switch to Bixlenvo will need to first take a two-day loading dose of Sunlenca alongside the new doublet before Bixlenvo can be taken by itself.
In framing the specific patients for whom Bixlenvo could most benefit, Gilead’s SVP of clinical development and head of virology, Jared Baeten, M.D., told Fierce earlier this year that “[t]his is a medicine, really, that is addressing some of the challenges of aging with HIV.”
The median participant age was 60 years in Aristry-1, making it the “oldest study population in a phase 3 registrational trial for HIV-1 treatment to date,” Gilead said in its approval announcement. Those older patients may be especially susceptible to drug resistance or other intolerance based on years of experience using earlier, “less robust therapies of the past,” Baeten said in an interview around the tablet’s pivotal trial results in February.
Meanwhile, Baeten told Fierce at the time that lenacapavir is at the heart of the California drugmaker’s current development efforts, noting that Gilead is hoping to offer an ever-widening armamentarium of HIV treatment and prevention options across formulation and dosing timelines.
Part and parcel to those efforts, Gilead has also set the goal to strike out on seven new HIV launches by the end of 2033. The company, together with its partner Merck & Co., recently detailed positive phase 3 results for what could be the first complete weekly pill for the treatment of HIV, combining lenacapavir with the New Jersey pharma’s nucleoside reverse transcriptase translocation inhibitor, islatravir.