A new once-daily pill to treat HIV just got the FDA’s green light

On Thursday, the Food and Drug Administration announced it has approved a new once-daily, single-pill HIV treatment, according to a report by CNBC.

The new pill, called Bixlenvo and created by Gilead Sciences, is an especially exciting development for people living with HIV because it provides them with another treatment option that contains a minimal amount of drugs. It combines bictegravir, the active ingredient in Gilead’s super successful HIV treatment Biktarvy, with lenacapavir, a capsid inhibitor that has become a key component in Gilead’s HIV treatment and prevention methods.

The new treatment is aimed at individuals whose HIV is already under control but who are still dealing with complicated treatment regimens. The FDA’s approval makes it the first single-pill regimen available for HIV+ adults whose virus is suppressed but who, for various reasons, are unable to use any of the single-pill treatments currently on the market, as noted in Gilead’s announcement. This represents about five percent of people living with HIV in the U.S.

This group is mostly comprised of older individuals with long treatment histories, says Dr. Jared Baeten, Gilead’s clinical development and virology therapeutic area head. He notes that many of these people “had to take handfuls of pills around 25 years ago,” in addition to the fact that HIV can accelerate other complications of aging, like heart disease, diabetes, and high cholesterol.

“It fulfills an unmet need, particularly for individuals who are on complex regimens who just would not otherwise consolidate down to something really meaningful for them and prescribers,” Baeten told CNBC. “But it’s also meaningful for individuals who are seeking options for something new,” he added, commenting on its viability as a treatment option for others outside of this demographic. “We want to build options that give people the opportunity to choose something that’s going to work for them and work for them for the long haul.”

Before discounts or rebates, the list price of Bixlenvo is $4,595 for a one-month supply, which is similar to other daily single-pill treatments. Those without health coverage may be eligible to receive it for free through Gilead’s patient assistance program, and people with insurance may be eligible for copay support.

Timothy Cameron, a retired Seattle resident who participated in the first Phase 3 trial, also spoke to CNBC about the exciting development.

Cameron, 64, has been living with HIV for more than 40 years. He says when he was first diagnosed in the 1980s, very few treatment options existed, and it was difficult for doctors to measure exactly how active the virus. He was prescribed various HIV treatments over the years, including experimental drugs and multi-pill regimens that often came with serious side effects. However, they all would eventually cease to control his “hard-to-treat” HIV.

“It was just like throwing darts at a dartboard,” Cameron said. “Because I had done so many drug trials and monotherapy, my virus had become super resistant.”

Fortunately, he survived those difficult years and finally found a regimen that controlled his HIV, but it required him to take a pill twice a day along with another drug. Then a few years ago, his doctor encouraged him to join the trial and switch to Bixlenvo.

Cameron says the transition was seamless and the new regimen has maintained control of his HIV without any notable side effects. Switching to the once-daily pill “smaller than my pinky nail” was a welcome relief after decades of treatment struggles

“It’s one less thing I’m putting in my body, and it preserves options if I need them,” Cameron said.