Is there a pill I can take every day to stay healthy?
That’s a question that Dr. Chloe Orkin frequently hears from her elderly HIV patients, who take several medications daily to keep the virus under control.
“They keep asking: ‘Why can’t I take just one pill? Or why can’t I take injections?’ And we have to keep saying: ‘No,’” explains Orkin, a doctor and researcher at Queen Mary University of London.
It’s not an impossible dream. Most of the 40 million HIV patients worldwide can already take one pill a day 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 early in the AIDS epidemic, in the 1980s and 1990s, “when we were still learning to treat HIV,” Orkin says. “They used medications that didn’t work as well and, as a result, developed resistance to those drugs.”
Another group of HIV patients who have developed resistance are those who couldn’t take their antiretroviral medications consistently.
The result? These people need to take many pills, several times a day, to keep the virus under control. Orkin says this represents a logistical challenge, but also because some medications have side effects — like diarrhea — and some patients take medications for other conditions that can interact problematically with antiretroviral drugs. For example, Orkin says, one type of antiretroviral medication, called a boosted protease inhibitor, can cause a person to suffer worse side effects from other non-HIV medications.
Tens of thousands of HIV patients in the US follow these complex regimens and many more worldwide, though Orkin and other experts say it’s hard to pinpoint an exact number.
“Science has advanced for everyone else except them,” Orkin says. “They are like a forgotten population.”
But soon, Orkin hopes to be able to answer her patients’ requests for a single daily pill with a new response: Yes! Here it is.
New research, published online on February 25 in the medical journal The Lancet, tested a new single daily pill developed to replace the complex multi-pill treatments that some HIV patients need to take.
“The medication worked as well as the complex regimen,” says Orkin, 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 works.”
The pill is manufactured by Gilead Sciences and combines two of its HIV medications — Bictegravir and Lenacapavir — into a single pill 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 as effective as the single-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, director of the Desmond Tutu HIV Centre 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 to improve treatment options for patients resistant to current single-pill treatments. “That small portion will grow,” she explains.
“When people need to take something for the rest of their lives, the ideal is to simplify it as much as possible. That way, you reach a point where more and more people can [keep taking their medications] and incorporate them into their lifestyle.” This, in turn, helps prevent HIV transmission, as a patient on medication has a viral load low enough that they cannot transmit the virus.
Additionally, she says the HIV virus is always mutating, so new medications are essential.
“We need to stay one step ahead,” she says. “We can’t stop. We did that with tuberculosis, right? We got four medications. Done. And then we got into big trouble.” The world now struggles with extremely drug-resistant tuberculosis. To avoid a similar fate for HIV, Bekker says, this kind of research developing new drugs and new drug combinations is essential.
Gilead Sciences stated in a press release that it will submit an application to the US Food and Drug Administration (FDA) “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 is concentrated — will be crucial. But Bekker says that, in recent years, the HIV/AIDS community has been an effective advocate for improving access when needed.
For now, Bekker says she’s just happy to see the study results. The past year has been tough, she says, with cuts in international aid causing major disruptions to HIV care systems and data. So, she says, it’s a relief for the HIV/AIDS community to receive such “very good” news.
Source: npr.org