The Food and Drug Administration has approved a once-daily HIV pill. gilead This could simplify care for some patients, the company announced Thursday.
The drug, sold as Bixlenvo, is aimed at patients whose virus is already under control but are still on a complex treatment regimen. It may also be attractive to people who simply want to switch to a new treatment.
The pill combines bictegravir, the backbone of Gilead’s hit HIV drug Biktarvy, with lenacapavir, a first-in-class capsid inhibitor that is central to the company’s long-term strategy for HIV treatment and prevention.
According to Gilead, the approval makes the new pill the first one-pill regimen available for HIV-infected adults who are virally suppressed but cannot use currently available one-pill treatment options. The company told CNBC that this population accounts for an estimated 5% or more of people infected with HIV in the United States.
Gilead told CNBC that the list price for the pill, before discounts and rebates, is $4,595 for a 30-day supply, which is the same as other once-a-day HIV medications. Those without health insurance may be able to obtain Bixlenvo for free through Gilead’s Patient Assistance Program, while those with commercial or private insurance may be able to receive out-of-pocket support through a separate savings program, the company said.
“This fills an unmet need, especially for individuals taking complex regimens, who otherwise would not be able to integrate them into something truly meaningful for them and their prescribers,” said Jared Baeten, Ph.D., Gilead’s head of clinical development and virology therapeutics.
“But it also has implications for individuals who are looking for the option of something new,” he continued. “We want to build options that give people the opportunity to choose what works for them and is likely to work for them long-term.”
There is no cure for HIV or AIDS. However, many people living with HIV can manage their disease by taking one pill each day. This is a treatment plan that Gilead helped develop 20 years ago.
However, some patients are unable to use existing one-pill options like Biktarvy due to drug resistance from older treatments, side effects and interactions with other drugs, and other treatment challenges and require more complex drug combinations. These patients may have to take multiple pills per day and adhere to complex dosing schedules.
Baeten said this group tends to be older and have a longer history of treatment, “some of whom had to take a few pills about 25 years ago.” HIV also promotes age-related complications such as heart disease, diabetes and high cholesterol in that age group, he added.
“In my opinion, developing drugs for people aging with HIV is very meaningful,” Baeten said.
The new tablet is also aimed at people who have had good results on single-tablet therapy containing Biktarvy but wish to switch to the new tablet. Baeten emphasized that Bixlenvo is not seeking to replace Biktarvy.
For patients who are already doing well on Biktarvy, the rationale for switching is rather to expand treatment options, he said. He emphasized that HIV care is highly individualized and long-term success often depends on finding the 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 tablets, weekly oral doses, and long-acting injectable therapies. The goal is to give patients flexibility in how they manage their disease, he said.
“We’re going to build enough choices so people can make choices that work for them,” Baeten said. “Some people like the certainty of once a day, while others want ‘set it and forget it’ once every six months.”
What does Bixlenvo mean to patients?
Gilead Bixlembo drug
Provided by: Gilead
Baeten said it was “essential” to have multiple HIV drugs because the virus can become resistant to initial treatment.
Combining bictegravir and lenacapavir in one pill “attacks the virus in two different ways” and allows for “high efficacy (and) strong protection” against viruses that are resistant to treatment, Baeten added.
The approval was based on two Phase 3 studies that evaluated Bixlenvo in adults with HIV whose virus was already suppressed on treatment. This includes people who have switched from Biktarvy or complex treatment regimens that use multiple pills.
The first trial, ARTISTRY-1, specifically enrolled long-treated and drug-resistant patients, many of whom were taking multiple HIV drugs each day. Participants had a median age of 60 years and were taking between 2 and 11 tablets daily before switching to Bixlenvo.
In both studies, the pill maintained viral suppression at a rate comparable to patients’ previous regimens at 48 weeks, was generally well-tolerated, and there were no new safety concerns. The most common side effects reported by at least 2% of participants across the two trials were headache, nausea, and diarrhea.
Timothy Cameron, a 64-year-old retired Seattle resident who has lived with HIV for more than 40 years, was one of 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 the virus’s activity. He spent decades testing HIV drugs, experimental drugs and combination therapy, which often had difficult side effects and eventually became ineffective against the “hard-to-treat” virus.
“It was like throwing darts at a dart board,” Prime Minister David Cameron said. “I did so many drug trials and monotherapy that my virus became very resistant.”
A few years before enrolling in Gilead’s study, Cameron finally found a regimen to control his virus, but it required him to take an HIV pill twice a day along with another medication. Doctors encouraged him to take part in a trial and switch to Vixulenbo, a once-daily pill that Cameron described as “smaller than my little fingernail.”
The transition was seamless, he said. The drug kept the virus under control without causing side effects, and simplified his treatment routine by reducing the number of pills he took and consolidating all his medications into one daily schedule.
For Cameron, who has spent decades navigating HIV treatment options as the virus develops resistance, one of the biggest advantages may be that the two-drug regimen effectively controls the virus while reducing exposure to the drug. This gives confidence that additional treatment options will continue to be available if needed, he said.
“It’s one less thing you’re putting into your body and it leaves you with options if you need them,” Cameron said.
