Gilead’s HIV Combination Tablet Bixlenvo Approved by FDA

Gilead Sciences is launching Bixlenvo, a new combination tablet for HIV treatment approved by the US Food and Drug Administration (FDA).

Gilead Sciences said on the 28th, local time, according to US pharmaceutical publication Fierce Pharma, that it had received FDA approval for Bixlenvo, a once-daily oral combination tablet for adults whose HIV is virologically suppressed.

Bixlenvo combines bictegravir, an established integrase strand transfer inhibitor (INSTI), with lenacapavir, a capsid inhibitor recently developed by Gilead.

The approval gives Gilead a new oral treatment option in the United States, following the company’s introduction of the first once-daily single-tablet HIV regimen about 20 years ago.

Bixlenvo links two eras in Gilead’s history. Bictegravir is one of the three components of Biktarvy, now a standard HIV treatment, and has helped lead Gilead’s HIV business in recent years.

Lenacapavir was first approved in 2022 as part of an HIV treatment option under the name Sunlenca. Last summer, it was approved as Yeztugo, an HIV preexposure prophylaxis (PrEP) injection administered twice yearly, signaling the next direction of Gilead’s HIV business.

Daniel O’Day, Gilead’s chief executive officer, said in a statement that the approval was meaningful for people with HIV seeking to change or simplify their treatment.

“Gilead’s goal is to provide a range of options for HIV treatment and prevention,” O’Day said.

The approval was based on data from the ARTISTRY-1 and ARTISTRY-2 studies, late-stage trials designed to enroll a broad range of people with HIV.

ARTISTRY-1 evaluated Bixlenvo in patients managing HIV with complex multiple-tablet regimens because of factors including acquired drug resistance, tolerability issues and drug interactions.

ARTISTRY-2 compared Gilead’s new 2-drug combination tablet with its Biktarvy and demonstrated noninferiority in maintaining viral suppression among patients who switched treatments.

Both studies used the proportion of patients with HIV-1 RNA levels of at least 50 copies/mL at week 48 as the primary endpoint. This is a standard measure for determining whether HIV is detectable.

Patients switching to Bixlenvo must first receive a loading dose of Sunlenca for 2 days before taking the new combination tablet alone.

Jared Baeten, Gilead’s senior vice president of clinical development and head of virology, said in an interview with Fierce Pharma earlier this year, “This is really a drug that addresses some of the challenges of growing older with HIV.”

The median age of participants in ARTISTRY-1 was 60 years, and Gilead said in its approval announcement that it was “the oldest study population to date among phase 3 registration trials for HIV-1 treatment.”

In an interview in February, when the key clinical results for the combination tablet were announced, Baeten explained that older patients may be particularly vulnerable to drug resistance or tolerability issues because they had used “less potent treatments” for years in the past.

Baeten also said that lenacapavir is at the core of Gilead’s current development efforts. Gilead expects to continue expanding HIV treatment and prevention options across formulations and dosing intervals.

As part of these efforts, Gilead has set a goal of launching seven new HIV products by the end of 2033.

Gilead recently announced positive phase 3 results for a candidate developed with partner Merck that combines lenacapavir with Merck’s nucleoside reverse transcriptase translocation inhibitor islatravir and could become the first complete once-weekly pill for HIV treatment.