FDA Approves Cabenuva, The First Monthly HIV Drug Treatment

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A new monthly HIV treatment — the first of its kind — could benefit hundreds of thousands of people currently taking daily pills to prevent the virus from leading to AIDS.

ViiV Healthcare, a Research Triangle Park-based biotechnology company, recently received approval from the U.S. Food and Drug Administration for a monthly treatment for HIV called Cabenuva.

ViiV, created out of a joint HIV-focused venture by GlaxoSmithKline and Pfizer, says the treatment is the only monthly treatment of HIV-1 infection in adults.

Rather than most treatments that are given orally everyday, Cabenuva is given once a month.

The treatment is administered as two individual injections — one injection of ViiV Healthcare’s cabotegravir and one injection of Janssen’s rilpivirine — once a month by a healthcare provider. It’s only being given to patients who already have suppressed HIV in their immune system.

The drug was tested in a clinical trial that included 1,182 HIV-infected adults who already had suppressed the virus in their bodies. The trials found that the monthly shot continued to show suppression of the virus, with the most common adverse reactions being fever, fatigue, nausea, and musculoskeletal pain.

ViiV Healthcare, founded in 2009, has a large presence in Research Triangle Park and has several ties to the area. The company has around 250 employees here and recently added more, thanks to the FDA’s approval of Cabenuva.

A portion of the clinical trials was run at UNC Hospitals, which has long been at the center of HIV research.

Dr. David Wohl, an infectious disease specialist at UNC Health, led the clinical trials for Cabenuva here. He told The News & Observer that the treatment could be hugely beneficial for many patients.

“We have come such a long way with HIV care and therapy,” Wohl said in an interview. “We are at a point now where we have wonderful coping therapies that are really one pill a day for most people. The days of handfuls of medicine are over for most.”

But these are medicines that patients take for the rest of their lives, Wohl said, and they do want to see them improve.

Many are taking other medicines every day, and they’d like the convenience of just one shot per month. A minority of people can struggle to swallow pills and might prefer a shot instead. Others might not take their daily pills consistently.

But for a lot of people, Wohl said, the once-a-month treatment might have a more psychological benefit.

“There is still a stigma associated with HIV. It has been going on for 40 years,” he said. “There’s also an internal stigma where people feel not good about themselves and taking a pill every day makes them realize daily they are living with an incurable virus.

“If I told you women only had one choice for contraception and I said, ‘We are all good, we have achieved our goal,’ a lot of folks would say we could do better,” Wohl said.

They’d want more options, he said, like a shot they can take every three months or an implant. And now they do, with a variety of options existing for women’s contraception.

That’s a future that is rapidly approaching for people with HIV, Wohl said.

“People in the ’80s were concocting treatments in their bathtub or going to Mexico (for treatments),” Wohl added. “They could only imagine there was a daily pill that could control HIV. We are there now. But can we do even better.”

That could include creating monthly injections for drugs that prevent HIV infections from occurring. Currently, treatments, like PrEP, are once-daily pills, but companies, like ViiV, are investigating potential long-lasting injections for that as well.

In 2020, there were 1,085 newly diagnosed HIV infections in North Carolina, a 21.3% decrease in cases from 2019, according to data from the N.C. Department of Health and Human Services.

Worldwide, there were 1.7 million new HIV infections in 2019, a decrease of 23% from 2010, the Barcelona Institute for Global Health reported.

Wohl said it appears as if the pandemic is decreasing the spread of HIV. Though, he said he’s worried the pandemic might cause fewer people to use safe needle exchanges, as shared needles are one of the more common causes of HIV transmission.

But regardless, Cabenuva should be good news for people around the world, he said.

CABENUVA’S COSTS

Cabenuva was first approved last year in Canada, and it has also been approved for use in the European Union. The drug is also under review in Australia and Switzerland, and ViiV said it plans to submit to other regulatory bodies around the world later this year.

The treatment could be too expensive for many, though. The first initiation injections have a wholesale acquisition cost — which doesn’t include potential discounts or rebates — of $5,940. The subsequent monthly injections would then have a wholesale acquisition cost of $3,960 per month.

That would likely make it more expensive for many who are on the daily pills. The daily-dosed regimens have varying costs, sometimes as low as hundreds of dollars per month to potentially thousands of dollars.

Wohl said that he’s hopeful ViiV and other manufacturers are careful about the pricing of these drugs.

“Companies have to make money,” he said. “But we have to make sure that people who can benefit from this have access.”

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