Twice-yearly HIV prevention injection approved by FDA
UNC School of Medicine’s Dr. Joe Eron led a clinical trial on the new medication, which could help stem the global epidemic.
The Food and Drug Administration approved the preventative use of lenacapavir, made by Gilead Sciences, in June.
The injection, which boasts a six-month-long period of effective protection, will help mitigate health care access gaps and prevent further infections brought on by low medication adherence.
Dr. Joe Eron, the Herman and Louise Smith Distinguished Professor of Medicine and director of the clinical core at the UNC Center for AIDS Research, played a hand in the clinicals trials leading up to FDA approval of the medication.
“This is game-changing development in our field,” said Eron, principal investigator of the clinical trial site at the UNC School of Medicine. “I honestly think if public health and medical institutions can deploy it to rural populations, this medication could help end the HIV epidemic, not only in North Carolina, but in the United States overall.”
Preventative therapies for HIV-1 have improved rapidly over the past decade. A once-daily pill named PrEP, or preexposure prophylaxis, has been a stalwart for HIV prevention, but only if people take it consistently and can routinely access a pharmacy.
In 2022, Gilead Sciences Inc. received U.S. Food and Drug Administration approval for lenacapavir, a twice-yearly injectable medication for adults with multidrug-resistant HIV. Clinical trials have shown that this medication could also serve as a preventative medication —particularly for those who struggle to pick up their prescriptions or stick to a daily pill regimen.
Now, the well-tolerated medication has been approved by the FDA as a new preventative medication for all adults, as well as adolescents weighing at least 35kg, who are at risk of acquiring HIV.
HIV epidemic in North Carolina
Here in North Carolina, about 38,634 people have HIV, the 11th highest HIV rate among U.S. states and the District of Columbia.
The blood-borne infection can be transmitted through anal or vaginal sex, or the sharing needles or syringes with an HIV-positive partner. Certain groups of people are more likely to get HIV than others, depending on their behaviors and geographic locations.
Infectious disease researchers and physicians, like Eron, have seen that HIV disproportionately affects those living in rural, underserved areas in the South, especially young men of color who have sex with other men.
This is because many rural areas of the South are considered to be health care deserts — areas where people cannot easily travel to pharmacies, primary care providers, hospitals or low-cost health centers. These can pose a huge challenge for people who need to grab their prescriptions — and to do so discreetly.
“North Carolina is no exception to that,” said Eron. “We see that young men of color who have sex with other men are not comfortable with taking PrEP, due to stigma and lack of health care access. This long-lasting injection is critical because it can be given in a private, medical setting just twice a year.”
Results from the third phase clinical trials of the medication were so impressive that Science magazine named lenacapavir its 2024 Breakthrough of the Year.
Eron and colleagues are now looking to get the drug to people who are at highest risk of HIV infection and who have difficulty coming in for frequent follow-up visits. The long protective properties of the drug are key.
“When people at risk leave prison or received opioid therapy, they’re at highest risk [of getting infection] over the next three to four months,” explained Eron. “A single shot could actually be the protection they need to keep themselves and their partners healthy.”
