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FDA Approves First Injectable Drug Regimen for Adults Living with HIV

Curated by Claudia Shannon / Research Scientist / ishonest

Suzi Stewart, 62, has been living with HIV since 2006, and has disliked the traditional daily treatment regimen of taking one pill a day for about 15 years.

For her, it’s been a constant reminder of her HIV status. So, it came as a relief when she found out about a clinical trial for a new monthly injectable HIV treatment.

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“I cried when I had to wait to get on it [the trial], I was so tired of taking that pill, it was like a party when I could go in and get my injection,” Stewart told ishonest. “It really felt like a party. I was finally off that pill.”

Stewart was part of the trial of Cabenuva, the first-ever long-acting injectable HIV treatment to receive Food and Drug Administration (FDA) approval. A Cabenuva treatment is comprised of two injectable medications: cabotegravir developed by ViiV Healthcare and rilpivirine from Janssen.

The medications are administered as intramuscular injections in the buttocks during one clinical visit.

Why is this significant? Instead of taking a pill every single day of the year, people living with HIV who opt for this treatment just have to receive a monthly injection from a healthcare provider.

The new approval

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In its announcement, the FDA also approved Vocabria, an oral pill version of cabotegravir, which people will have to take daily along with an oral form of rilpivirine for a month before starting the new injection regimen.

This is to ensure they can tolerate the new medications before adopting the new course of treatment.

Dr. David Wohl, a professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, said this new development offers a major advancement in how we treat HIV.

A clinical trial investigator for Cabenuva, Wohl told ishonest that the new advancement reflects all of the progress that’s been made in recent years, recalling the AIDS crisis when people were forced to “make their own antiretrovirals in their bathtubs.”

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Advances in more inclusive care and strides in research have significantly improved, to the extent where people with HIV can live long, healthy lives, with medications allowing them to achieve undetectable status.

This means that as long as they adhere to their regular antiretroviral treatments, the HIV viral load in their blood will be at levels so low that the virus can no longer be detected.

People who are undetectable are unable to transmit the virus to sexual partners, for instance, according to the Centers for Disease Control and Prevention (CDC).

Facing stigmas

“What’s very unique about HIV, which is different than taking a pill for your diabetes, is that unfortunately, there is stigma that has been tagged to living with HIV,” Wohl said. “Some of that stigma is external — some people don’t want other people to see their pills in their medicine cabinet, or in their purse or backpack.”

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He added that there’s also an “internal stigma.” It can be difficult to face living with HIV every day, to be reminded about one’s status by having to take a pill every day.

“It can force people to have a stigma against themselves. In many ways feeling guilty, feeling bad, feeling dirty — those are unfortunately things people are saddled with,” he said.

“There’s pretty ample, well-done research that shows this will remind people of their HIV,” Wohl said. “So, from that to not having to think about it, to just go in one month for an injection, they can go back to as close to what they consider as normal as possible by getting a shot every month.”

Wohl added: “On a psychological basis, I think for many people it will be a benefit.”

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Dr. Alan Taege, an infectious disease expert at Cleveland Clinic, said he was initially surprised to see the public results of the trial and see just how many participants preferred taking an injectable medication over a pill.

“Every day millions of people in this country take pills for all kinds of things, but the younger you are, sometimes it’s harder to remember [to take a pill], and also, when you get older, you start forgetting things, too,” Taege told ishonest.

Taege, who was not involved with the trial, said that we won’t necessarily see a mass adoption of this new drug. For one thing, it depends on supply and storage.

The drug will need to be stored at low temperatures, and facilities will have to have the space and capacity to have the right amount of supplies. It will also depend on typical medication concerns of who can afford what and what insurance will cover.

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Another concern: Some people don’t like getting injections.

Taege envisions a future where this is an accessible option, where people living with HIV can choose between this and more traditional forms of medication.

Wohl recalled treating a man with HIV years ago who said his “ideal regimen” of taking pills was “the closer you get me to zero, the better.”

He said it’s no secret that people want to take fewer drugs, they don’t want to be staring at that small tablet each and every day.

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Wohl thinks we’ll be heading into a near future where more of these kinds of injectable drugs will be the norm and, like Taege, added that they’ll give people a choice.

‘A breakthrough’

“Some people describe this as a breakthrough in HIV treatment simply because of the potential convenience and privacy of the patient, which is something I think will be good for a number of patients, and we’ll see how many in the long term adopt this,” Taege said. “Hopefully we can make it so that it can help all patients have a better life.”

Wohl added that this can’t be understated. “It’s a really big deal, it’s historic,” he said.

Now, the challenge will be to make sure it’s widely disseminated. It can’t just reach New York or San Francisco. He said it needs to be in places where HIV has hit the hardest and where people need access to new and better therapies, such as Johannesburg, South Africa, and Monrovia, Liberia.

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When Stewart, who lives in Iowa, reflects back on her own journey with HIV, she said she feels lucky. She has a supportive family who have never stigmatized her because she’s living with HIV.

She said she’ll never forget when she first found out about her status: She had flu-like symptoms that kept getting worse, and weight loss. A scope examination found she had thrush wrapped around her esophagus.

Her doctor asked her if she had been tested for HIV before and when she said “no,” she was tested and found the results. At the time, she was living with her mother, who was nothing but supportive.

“I was extremely ill, I was very sick, like really close to dying, actually. It was a blessing that I got the help I needed right away,” Stewart said.

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Today, she’s in good health and is happy to be on this new medication as well as be in a position to share her story with others.

“I just am blessed with a wonderful family and friends who accepted it right away. I have grandbabies and a great-grandson. And I’ve learned you have to live for yourself and the people who love you. but it’s a personal choice,” she said when discussing selecting the right medication for you.

“It’s to each his own,” she said. “But for me, it was a wonderful choice.”

Read more on: regimen, aids


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