FDA approves Gilead HIV pill Bixlenvo designed to simplify treatment

The Food and Drug Administration approved a once-daily HIV pill from Gilead that could help simplify care for some patients, the company announced Thursday. 

The drug, marketed as Bixlenvo, is aimed at patients whose virus is already under control but who remain on complicated treatment regimens. It could also appeal to those who simply want to switch to a new treatment alternative.

The tablet combines bictegravir, the backbone of Gilead’s blockbuster HIV pill Biktarvy, with lenacapavir, a first-in-class capsid inhibitor that has become a centerpiece of the company’s long-term strategy for HIV treatment and prevention. 

The approval makes the new pill the first single-tablet regimen available for adults with HIV whose virus is suppressed but are unable to use currently available one-pill treatment options, according to Gilead. That population accounts for an estimated 5% or more of individuals in the U.S. living with HIV, the company told CNBC. 

The list price of the pill before discounts or rebates is $4,595 for a 30-day supply, which is in line with other daily single-tablet HIV treatments, Gilead told CNBC. People without health insurance may be eligible to get Bixlenvo for free through Gilead’s patient assistance program, while those with commercial or private insurance may be able to receive co-pay support through another savings program, the company said.

“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,” Dr. Jared Baeten, Gilead’s clinical development and virology therapeutic area head, said in an interview ahead of the approval. 

“But it’s also meaningful for individuals who are seeking options for something new,” he continued. “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.”

There is no cure for HIV or AIDS. But many people living with HIV can manage the disease by taking a single pill daily, a treatment plan that Gilead helped pioneer two decades ago. 

But some patients can’t use any existing one-tablet options like Biktarvy and require more complex combinations of medicines because of drug resistance from older therapies, side effects or interactions with other drugs, among other treatment challenges. Those patients may have to take multiple pills a day and adhere to complicated dosing schedules.

Baeten said that group tends to be older and have long treatment histories, saying “some had to take handfuls of pills around 25 years ago.” HIV also accelerates complications of aging, such as heart disease, diabetes and high cholesterol, in that age group, he added. 

“It’s incredibly meaningful to develop a medicine, in my perspective, for people aging with HIV,” Baeten said. 

The new pill is also aimed at people who are doing well on a single-tablet regimen, including Biktarvy, and want to switch to a new one. Baeten stressed that Bixlenvo does not aim to replace Biktarvy. 

For patients already doing well on Biktarvy, the rationale for switching is more about expanding treatment choices, he said. He emphasized that HIV care is highly individualized and that long-term success often depends on finding a regimen that best fits a patient’s preferences and lifestyle.

Baeten also said Bixlenvo is part of Gilead’s broader effort to build a range of HIV treatment options around lenacapavir, including daily pills, weekly oral regimens and long-acting injectable therapies. The goal is to give patients flexibility to choose how they want to manage the disease, he said.

“We’re going to build enough options that people can make the choice that’s going to work for them,” Baeten said. “Some people like the surety of once a day, and some people would want ‘set it and forget it’ once every six months.”

Baeten called it “essential” to have more than one medicine to treat HIV because the virus can become resistant to an initial treatment.

Combining bictegravir and lenacapavir in one pill allows it to “hit the virus in two different ways” with “high efficacy [and] strong protection” against the virus becoming resistant to treatment, Baeten added.

The approval is based on two Phase 3 trials, which evaluated Bixlenvo in adults with HIV whose virus was already suppressed on treatment. That includes people who switched from Biktarvy or complex treatment regimens with multiple tablets. 

The first trial – ARTISTRY-1 – specifically enrolled patients with long treatment histories and drug resistance, many of whom were taking multiple HIV medications each day. Participants had a median age of 60 and were taking between two and 11 pills daily before switching to Bixlenvo. 

In both studies, the pill maintained viral suppression at rates comparable to patients’ previous regimens at 48 weeks and was generally well tolerated with no new safety concerns. The most common side effects reported in at least 2% of participants across the two trials was headache, nausea and diarrhea. 

Timothy Cameron, a 64-year-old retired Seattle resident who has been living with HIV for more than 40 years, was among the participants in the first Phase 3 trial.

When he was first diagnosed in the 1980s, doctors had few treatment options and little ability to measure how active the virus was. He spent decades cycling through HIV medications, experimental drugs and multi-pill regimens that often came with difficult side effects and eventually stopped working against his “hard-to-treat” virus.

“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.”

A few years before enrolling in the Gilead study, Cameron finally found a regimen that controlled his virus, though it required taking one HIV pill twice daily along with another medication. His doctor encouraged him to join the trial and switch to Bixlenvo, a once-daily pill Cameron described as “smaller than my pinky nail.”

The transition was seamless, he said. The drug maintained control of his virus without causing side effects and simplified his treatment routine by reducing the number of pills he takes and consolidating all of his medications into a single daily schedule.

For Cameron, who spent decades exhausting HIV treatment options as his virus developed resistance, among the biggest benefits may be that the two-drug regimen effectively controls his virus while exposing him to fewer medications. He said that gives him confidence that additional treatment options could remain available in the future if he ever needs them.

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