Is there one pill a day to keep me healthy?
That's a question that Dr. Chloe Orkin hears a lot from her older HIV patients who take many medications each day to keep the virus under control.
"They keep asking: 'Why can't I have a single pill? Or can I have injections?' And you have to keep saying: 'No,'" explains Orkin, who is a physician and a researcher at Queen Mary University of London.
It's not a pipe dream. Most of the world's 40 million HIV patients can already take a single daily pill each day to keep the virus at bay or injections every two months.
But these treatment options don't work for many of Orkin's patients, especially the HIV patients who were diagnosed in the early days of the AIDS epidemic, in the '80s and '90s "while we were learning about how to treat HIV," says Orkin. "They had drugs that didn't work that well, and therefore they developed some resistance to these medications."
Another group of HIV patients who've developed resistance are those who have not been able to take their HIV medications consistently.
The result? These individuals must take many pills, multiple times a day, to keep the virus in check. Orkin says this is challenging logistically but also because some of the drugs have side effects — such as diarrhea — and some patients are taking medications for other conditions that can have problematic interactions with the HIV medications. For example, Orkin says, a type of HIV medication, called boosted protease inhibitors, can mean a person suffers worse side effects from the other non-HIV drugs.
Tens of thousands of HIV patients in the U.S. are on these complex regimens and many more globally, although Orkin and others say it's hard to pin down an exact number.
"Science has moved on for everyone else except for them," Orkin says. "They're like a forgotten population."
But soon, Orkin hopes to be able to answer her patients' pleas for a single daily pill with a new answer: Yes! Here it is.
New research, published online on February 25 in the medical journal The Lancet, tested a new single daily pill designed to replace the complex multi-pill treatments some HIV patients must take.
"The drug worked just as well as the complex regimen," says Orkin, who is the lead author on the study which tested the new single pill in a group of 550 HIV patients on the complex regimens. "And if it works in these people then it really, really works."
The pill is made by Gilead Sciences and combines two of their HIV drugs — Bictegravir and Lenacapavir — into one tablet that's smaller than a multivitamin.
Gilead supported the research but it was done by academics and physicians at more than 90 independent sites from South Africa to the Dominican Republic, from Japan to France. Another study – presented this past week at the Conference on Retroviruses and Opportunistic Infections held in Denver — found this new pill is also as good as the single-tablet pill, Biktarvy, that is one of the most widely prescribed HIV treatments in the U.S. and is recommended as a first‑line option in U.S. treatment guidelines.
"This good news is terrific," says Dr. Linda-Gail Bekker. Bekker, who directs the Desmond Tutu HIV Center at the University of Cape Town in South Africa, wasn't involved in the study.
She says the value of this new pill goes far beyond its potential role in improving the treatment options for patients who have resistance to the current single-pill treatments. "That smallish fraction is going to grow," she explains.
"When people have to take something for the rest of their lives, you want to simplify it as much as possible. So, you get to that point where more and more people can [keep taking their medications] and adopt it into their lifestyle." That, in turn, helps prevent HIV from spreading further, since the viral load of a patient on medication drops low enough they cannot transmit the virus.
Plus, she says, the HIV virus is always mutating, so new medications are essential.
"We've got to be ahead of the game," she says. "We can't stop. We did that with tuberculosis, right? We got four drugs. We're done. And then we were in big trouble." The world is now battling extremely drug-resistant TB. To avoid a similar fate for HIV, Bekker says, this type of research that develops new drugs and new drug combinations is key.
Gilead Sciences said in a statement that it will file an application with the U.S. Food and Drug Administration in "the near future" to get the new pill licensed. If approved, it is expected to launch in the second half of this year.
Future decisions about the pricing and availability in lower-income countries — where most of the HIV/AIDS burden remains — will be critical. But Bekker says that in the recent past, the HIV/AIDS community has been an effective advocate for improved access when necessary.
For now, Bekker says, she's just happy to see the study results. This past year has been a tough one, she says, with international aid cuts causing major disruptions for HIV care and data systems. So, she says, it's a relief for the HIV/AIDS world to get a bit of "very good news."
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