Gilead Bixlenvo drug

Courtesy: Gilead

The Food and Drug Administration has approved a once-daily HIV pill Gilead This 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 continue to receive complicated treatment regimens. It may 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 HIV treatment and prevention strategy.

The approval makes the new pill the first single-pill therapy for adults with HIV whose virus is suppressed but cannot take advantage of currently available single-pill treatment options, according to Gilead. This population accounts for an estimated 5% or more of people in the U.S. living with HIV, the company told CNBC.

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

“It fills an unmet need, particularly for people undergoing complex therapy who would otherwise not be focused on something that really matters to them and their prescribers,” said Dr. Jared Baeten, Gilead’s head of clinical development and virology therapeutics, in a pre-approval interview.

“But it is also important for individuals who are looking for opportunities to do something new,” he continued. “We want to create options that give people the opportunity to choose something that works for them and will work for them in the long term.”

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

However, some patients are unable to use existing one-tablet options such as Biktarvy and require more complex drug combinations due to, among other things, drug resistance to older therapies, side effects or interactions with other medications. These patients may need to take several tablets per day and adhere to complicated dosing schedules.

Baeten said the group tended to be older and have a long treatment history, saying, “Some had to take a handful of pills about 25 years ago.” HIV also accelerates complications of aging such as heart disease, diabetes and high cholesterol in this age group, he added.

“In my view, developing a drug for elderly people with HIV is incredibly important,” said Baeten.

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 emphasized that Bixlenvo does not intend to replace Biktarvy.

For patients who are already doing well with Biktarvy, the reason for the switch is more to expand treatment options, he said. He emphasized that HIV care is highly individualized and that long-term success often depends on finding a therapy that best fits a patient’s preferences and lifestyle.

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

“We will create enough options so that people can make the choice that works for them,” Baeten said. “Some people like security once a day, others like to set it and forget it every six months.”

How Bixlenvo is for patients

Gilead Bixlenvo drug

Courtesy: Gilead

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

By combining bictegravir and lenacapavir in one pill, the virus can be fought “in two different ways” with “high effectiveness.” [and] “strong protection” against the virus becoming resistant to treatment, Baeten added.

The approval is based on two phase 3 studies that evaluated Bixlenvo in adults with HIV whose virus was already suppressed by treatment. These include people who have switched from Biktarvy or complex multi-tablet treatment regimens.

The first study – ARTISTRY-1 – specifically included patients with long treatment histories and drug resistance, many of whom were taking multiple HIV medications daily. Participants were on average 60 years old and took between two and 11 tablets daily before switching to Bixlenvo.

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

Timothy Cameron, a 64-year-old retiree from Seattle 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 had little ability to measure how active the virus was. He spent decades going through HIV medications, experimental drugs and multi-pill regimens that often came with serious side effects, and eventually stopped working against his “hard-to-treat” virus.

“It was like throwing darts at a dart board,” Cameron said. “Because I had done so many drug trials and monotherapies, my virus had become super-resistant.”

A few years before enrolling in the Gilead trial, Cameron finally found a treatment that controlled his virus, although it required taking an HIV pill twice daily along with another medication. His doctor encouraged him to take part in the study and switch to Bixlenvo, a once-daily pill that Cameron described as “smaller than my little 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 took and combining all of his medications into a single daily schedule.

For Cameron, who spent decades exhausting HIV treatment options as his virus developed resistance, one of the biggest benefits may be that the two-drug regimen effectively controls his virus while exposing him to fewer medications. He said this gives him peace of mind that more treatment options may be available in the future should he ever need them.

“It’s one less thing I’m putting into my body and it maintains options when I need them,” Cameron said.

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