The injectable, which is administered every two months, is a replacement for the existing daily pill regimen.
The Food and Drug Administration said on Monday that the first injectable pre-exposure prophylaxis (PrEP) drug to reduce the risk of contracting HIV through intercourse has been authorized
PrEP has previously only been accessible as a medication. Apretude (cabotegravir extended-release injectable suspension) is a novel drug that is administered in two doses, one month apart, and thereafter every two months, according to the FDA.
In a statement, Debra Birnkrant, MD, director of the FDA’s Center for Drug Evaluation and Research, stated, “Today’s approval adds a vital tool in the quest to end the HIV pandemic by giving the first alternative to prevent HIV that does not need taking a daily pill.” “This injection, given every two months, will be essential in combating the HIV pandemic in the United States, especially assisting high-risk persons and some populations whose adherence to daily medicine has proven difficult.”
The FDA made its decision based on the results of two clinical trials that demonstrated the PrEP injectable to be effective in preventing HIV infection in individuals who used it. 4,566 cisgender males and transgender women who had sex with men took part in the first trial. Apretude or Truvada, a PrEP medication, was administered to the participants. Researchers discovered that people who used Apretude had a 69 percent lower chance of contracting HIV than those who took Truvada.
In a second trial, 3,224 cisgender women were randomly assigned to take either Apretude or Truvada. When compared to those who used Truvada, those who took Apretude had a 90% reduced chance of contracting HIV.
PrEP use is growing in the United States, according to preliminary statistics from the Centers for Disease Control and Prevention (CDC), although it is still low. PrEP was administered to around 25% of the 1.2 million persons who potentially benefit from it in 2020, compared to only about 3% in 2015.
What exactly is PrEP?
PrEP stands for pre-exposure prophylaxis. It’s designed for those who are at risk of contracting HIV as a result of sex or injectable drug use. When used as directed, it is “very effective,” according to the CDC.
Previously, the Food and Drug Administration (FDA) has authorised two drugs for use as PrEP:
Truvada is a medicine designed to protect people from contracting HIV through intercourse or injectable drug usage.
Descovy is a treatment for those who are at risk of contracting HIV through intercourse. (Descovy is not for those who were born with the gender feminine and are at risk of contracting HIV through vaginal intercourse.)
Apretude is the first injectable PrEP medicine available, and both meds are used once a day.
What is the need for injectable PrEP?
According to Perry N. Halkitis, PhD, MPH, dean of the Rutgers School of Public Health, “any item in the armory is beneficial.” “Most individuals use Truvada and Descovy on a daily basis. Individuals are more inclined to engage in a given health habit if it is not necessary on a daily basis.”
Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security and an infectious disease expert, agrees. He tells Health that eliminating the requirement to take a daily medication will improve compliance.
According to Dr. Adalja, an injection is also “more discreet” than having a bottle of pill laying around the house. “That might help to alleviate some of the stigma associated with PrEP,” he says.
People on Apretude will also need to see their doctor every two months, according to Halkitis. “With Truvada and Descovy, you already have to go every three months for a fresh prescription,” he points out.
Apretude will be shipped to distributors early next year, according to a spokeswoman for the drug’s producer, ViiV Healthcare, as reported by the Washington Post. Doctors are optimistic that having another PrEP choice would improve the number of patients who really use it. “Hopefully, this will assist increase the number of patients taking PrEP,” Dr. Adalja said. “At the end of the day, that should lower HIV rates in the country.”