People at high risk for HIV infection have already been able to take daily tablets in order to prevent infection, but many do not because of stigma or difficulties obtaining healthcare, paying for prescriptions, or adhering to a regular medication schedule.
However, there is now a new approach for preventing HIV without the need for daily tablets!
The Food and Drug Administration (FDA) has approved the first injectable HIV pre-exposure prophylaxis treatment, giving at-risk people another way to avoid sexually transmitted HIV.
The Food and Drug Administration announced on Monday that the drug, known as Apretude, will be made available to at-risk adults and adolescents who weigh at least 77 pounds and have previously tested negative for HIV, according to the agency. Because of the FDA’s approval, patients can now receive injectable drugs instead of daily HIV prevention oral medications such as Truvada. Apretude, on the other hand, necessitates two injections one month apart to get started, followed by two-monthly injections after that.
In two clinical trials conducted in 13 countries, it was discovered that Apretude was more effective than Truvada at preventing HIV infection. In a study of over 4,500 cisgender men and transgender women who have sex with men, participants who received the injectable medicine after taking the oral pill cabotegravir were 69 percent less likely to become infected with HIV.
The other trial, which included almost 3,200 HIV-positive cisgender women, found that those who used Apretude plus cabotegravir had a 90% lower risk of contracting HIV than those who took Truvada.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, director of the FDA’s Center for Drug Evaluation and Research’s Division of Antivirals.
The FDA anticipates that the injectable option will increase uptake among high-risk groups, such as young men who have sex with males and those with substance use disorders, depression, or poverty, who are less likely to take their prescription regularly. According to the Centers for Disease Control and Prevention, males who have sex with men made up 66 percent of all new HIV diagnoses in 2019.
ViiV Healthcare, which is majority-owned by GlaxoSmithKline, will begin shipping Apretude to distributors in the United States early next year, according to a press release. The United States is the only country to have approved Apretude thus far.
Approximately 1.7 million new HIV cases are discovered each year. Those who become HIV-positive while taking Apretude should start an HIV treatment regimen right away.
In two trials conducted in 13 countries, Apretude was found to be more effective than Truvada at preventing HIV infection. In a study of over 4,500 cisgender men and transgender women who have sex with men, those who took the injectable medicine after taking the oral pill cabotegravir were 69 percent less likely to become infected with HIV.