Is there a once-a-day pill to keep me healthy?
That’s a question that Dr. Chloe Orkin hears a lot from her older HIV patients, who take many medications every day to keep the virus under control.
“They keep asking: ‘Why can’t I have a single pill? Or can I take injections?’ And you have to keep saying: ‘No,’” explains Orkin, who is a doctor and researcher at Queen Mary University of London.
It’s not an impossible dream. Most of the 40 million people with HIV worldwide can already take a single daily pill to keep the virus under control or injections every two months.
But those treatment options don’t work for many of Orkin’s patients, especially those diagnosed in the early days of the AIDS epidemic, in the 1980s and 1990s, “while we were learning how to treat HIV,” Orkin says. “They used medications that didn’t work as well, and therefore developed some resistance to those drugs.”
Another group of HIV patients who have developed resistance consists of those who couldn’t take their HIV medications consistently.
The result? These people need to take many pills, several times a day, to keep the virus under control. Orkin says that’s logistically challenging, but also because some of the drugs have side effects — like diarrhea — and some patients take medications for other conditions that can have problematic interactions with HIV drugs. For example, Orkin says, one type of HIV medication called boosted protease inhibitors can mean the person suffers worse side effects from other non-HIV medications.
Tens of thousands of HIV patients in the US are on these complex regimens, and many more worldwide, though Orkin and others say it’s hard to determine an exact number.
“Science has advanced for everyone else except them,” Orkin says. “They are like a forgotten population.”
But soon, Orkin hopes she can respond to 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 that some HIV patients need to take.
“The drug worked as well as the complex regimen,” says Orkin, who is the lead author of the study that tested the new single pill in a group of 550 HIV patients on complex regimens. “And if it works in these people, then it really, really works.”
The pill is manufactured by Gilead Sciences and combines two of its HIV medications — Bictegravir and Lenacapavir — into a tablet that’s smaller than a multivitamin.
Gilead supported the research, but it was conducted by academics and doctors at more than 90 independent sites, from South Africa to the Dominican Republic, Japan to France. Another study — presented last week at the Conference on Retroviruses and Opportunistic Infections, held in Denver — found that this new pill is also as good as the single-tablet pill Biktarvy, one of the most prescribed HIV treatments in the US and recommended as a first-line option in US treatment guidelines.
“This good news is fantastic,” says Dr. Linda-Gail Bekker. Bekker, who directs the Desmond Tutu HIV Center at the University of Cape Town in South Africa, was not involved in the study.
She says the value of this new pill goes far beyond its potential role in improving treatment options for patients resistant to current single-pill treatments. “That small fraction will 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 the 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 a patient’s viral load on medication drops enough that they cannot transmit the virus.
Additionally, she says, the HIV virus is always mutating, so new drugs are essential.
“We have to stay ahead of the game,” she says. “We can’t stop. We did that with tuberculosis, right? We had four drugs. We’re good. And then we got into big trouble.” The world is now battling extremely drug-resistant TB. To avoid a similar fate for HIV, Bekker says, this kind of research that develops new drugs and new drug combinations is fundamental.
Gilead Sciences said in a statement that it will submit an application to the U.S. Food and Drug Administration “soon” for approval of the new pill. If approved, it is expected to launch in the second half of this year.
Future decisions on pricing and availability in low-income countries — where most of the HIV/AIDS burden remains — will be crucial. But Bekker says that in the recent past, the HIV/AIDS community has been an effective advocate for improved access when needed.
For now, Bekker says, she’s just happy to see the study results. Last year was tough, she says, with cuts in international aid causing major disruptions in HIV care and data systems. So, she says, it’s a relief for the HIV/AIDS world to get some “very good news”.
Source: npr.org