A new treatment for people living with HIV will soon be available — and a community health center in North Texas participated in the global clinical trial.
Prism Health North Texas was one of 32 sites to enroll patients in the clinical trial for Idvynso. The U.S. Food and Drug Administration approved the treatment for people living with HIV earlier this week.
“We are not in a position where in Dallas or anywhere in North America that 95% of our patients are undetectable, or preferably even 100%,” said Dr. Gary Sinclair, the medical director of clinical research at Prism Health. “That means that there are ways in which patients could be better served in new medications, new therapeutic options, particularly ones that involve a brand-new class.”
Sinclair said it’s common for people living with HIV to change their medication regimen due to concerns about side effects, tolerability, as well as the size and number of pills required.
“This medication offers a new option for people that are dissatisfied with their current treatment and gives them the ability to switch to a different regimen that may better meet their needs,” he said.
Merck, the pharmaceutical company behind the new treatment, expects it to be available in pharmacies after May 11. The treatment is a replacement for other FDA approved HIV regimens.
What’s unique about this treatment?
Sinclair said the most common HIV regimens rely on what are known as “integrase inhibitors.”
HIV, or human immunodeficiency virus, attacks the cells within the body’s immune system that help the body fight infection. The virus has to enter those cells and make copies of itself to spread.
HIV does this by using an enzyme called integrase. Once the virus makes copies, those are released and spread to other cells.
Integrase inhibitors interrupt the life cycle of HIV by preventing the virus from being able to make the enzyme.
“We've got a lot of great drugs to treat HIV these days, and they work for most people, but the operative word there is ‘most,’” Sinclair said. “We are beginning to see, as we have seen with every class of HIV medication, the slow advance of resistance to that class.”
While that resistance isn’t a big problem in the U.S., low- or middle-income countries are starting to see increasing rates of resistance.
“As the only two-drug, non-INSTI, tenofovir-free regimen, Idvynso expands therapeutic diversity beyond the currently available oral treatment options,” Dr. Eliav Barr, senior vice president and chief medical officer for Merck Research Laboratories, said in a statement.
As part of the clinical trial that some Prism Health patients participated in, Merck was able to demonstrate that the new treatment had a similar ability to suppress HIV replication compared to the other HIV treatments that rely on integrase inhibitors — like Biktarvy, the top-selling drug of Merck’s competitor, Gilead.
The goal of these treatments is to get patients to “undetectable” status, meaning the presence of HIV in the blood can’t be detected in standard lab testing. Viral loads that are low enough to be undetected means the virus is controlled and can’t be transmitted sexually.
Idvynso has not been approved for patients who are just starting therapy. Sinclair said Prism is participating in a clinical trial to test that, and said the data “looks promising.”
“In addition to being an option for people who wish to switch, I'm delighted that, for once, we have a medication that would work if the integrase class no longer is as effective for as many people as it used to be,” Sinclair said. “And that we have this option in advance of any kind of major crisis where we're beginning to run out of options for our patients.”
Addressing needs in North Texas
Dallas County’s HIV prevalence rate is nearly double that of Texas. Dallas County Health and Human Services reports there was about a 30% increase in new male HIV cases and more than a 6% increase in new female cases occurring in 2021.
Prism Health provides health services to the LBGTQIA+ community and operates as a federally-qualified health center look-alike – which makes services more accessible for underserved populations like people who are uninsured or underinsured.
“I'm very proud that as a federally qualified community health center look-alike, we can offer cutting-edge interventions, including Idvynso to our patients, as rapidly as any of the more prominent university players that are also doing research,” Sinclair said. “It's pretty amazing to be able to be this much on the cutting edge and still serve the population that Prism Health North Texas serves.”
Abigail Ruhman is KERA’s health reporter. Got a tip? Email Abigail at aruhman@kera.org.
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