The US Food and Drug Administration recently approved a twice-a-year injection that can be used to prevent HIV. The drug is currently used to treat certain HIV infections.
A drug that is currently being used to treat certain HIV infections was recently approved by the US Food and Drug Administration (FDA) to be used to prevent HIV. Lenacapavir is the name of the drug made by Gilead Sciences, which will be distributed under the brand name Yeztugo.
Within its clinical trial, the injection was found to drastically reduce the risk of HIV infection as well as provide a near-total protection against the disease, according to reports from CNN. It was found that lenacapavir also provides significantly more protection from other currently available options such as PrEP.
There are currently a multitude of HIV prevention and protection medications and therapies available in the US, so the approval of lenacapavir is a great addition to provide Americans with the most amount of protection.
“Yeztugo could be the transformative PrEP option we’ve been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Dr. Carlos del Rio, a professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research, in a Gilead news release.
“A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face.”
“We also know that, in research, many people who need or want PrEP prefer less frequent dosing,” Dr. Carlos stated.
“By having [PrEP] in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It prevents infection from taking hold,” said Dr. Jared Baeten, senior vice president of clinical development and the virology therapeutic area head at Gilead Sciences.
In a study by Gilead called the PURPOSE 2 trial, two shots a year of lenacapavir can reduce the risk of HIV infection by 96%, offering nearly complete protection against HIV. In Gilead’s PURPOSE 1 trial, the two shots were found to offer 100% HIV prevention in women.
“Lenacapavir is a unique option for people for HIV prevention because it’s an injection given just twice a year. So people can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later. For many people, that might be the empowered, private option that might make HIV prevention workable in their lives,” Dr. Baeten said.
Gilead Sciences has been behind a lot of advancement when it comes to HIV protection and prevention. In 2012 the FDA approved Truvada from the company, which was the first PrEP medication for HIV prevention in adults who are uninfected.
In the PURPOSE 2 trial, Gilead released data last year that showed 99.9% of the participants who received two injections of lenacapavir did not become infected. In terms of side effects, Baeten stated that “The most common side effects, as you might expect, are injection-site reactions,” like rashes or discomfort.
“This is a milestone moment in the decades-long fight against HIV. With twice-yearly administration and remarkable efficacy, lenacapavir will help us prevent HIV on a scale never seen before,” said Daniel O’Day, chairman and chief executive officer at Gilead Sciences, in an emailed statement to CNN.
“After 17 years of research and pioneering clinical trials, Gilead scientists have delivered the next frontier in HIV innovation: a prevention medicine with remarkable efficacy that only needs to be delivered twice a year,” he said.
“It’s a true scientific breakthrough that could help millions of people around the world.”
“Now that lenacapavir has been approved for prevention, people should be able to visit their providers and ask about the drug within two days,” Gilead Sciences said.
The list price for the infections will be announced soon and will likely be different when the drug is used for treatment of multidrug-resistant HIV, where other medications have not worked to the fullest extent.
The Journal of Antimicrobial Chemotherapy published a study in the fall that found for lenacapavir treatment, it would cost about $45,000 per person every year without insurance, but can be mass produced to cost less than $100 per person annually.
Specifically, the drug can be mass produced to cost $93 per person per year and could potentially cost as low as $40 a person “if voluntary licences are in place and competition between generic suppliers substantially improves.”
“Voluntary licensing and multiple suppliers are required to achieve these low prices. This mechanism is already in place for other antiretrovirals,” the researchers wrote.
“The hope is that PrEP tools could lead to a total halt to new HIV infections in future generations. Every one of us would like nothing more than to end this epidemic, and that’s what really solid prevention can do for us – that coupled with testing and treatment,” Baeten said.
“I want this next generation to think about HIV as something that they can end in their lifetime, end in their generation. And I want their next generation to be one where they’ve never had to think about HIV at all,” he said.
“We’ve got this amazing opportune moment right now as a world to think about where we can be in the future. We can be a world without HIV.”
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at eric.mastrota@thenationaldigest.com.
