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First FDA Approval for HIV Prevention Injection

The Food and Drug Administration (FDA) has approved the first injectable HIV pre-exposure prophylaxis therapy, giving at-risk persons another choice for preventing sexually transmitted The FDA stated on Monday that the medicine, called Apretude, will be offered to at-risk adults and adolescents who weigh at least 77 pounds and have previously tested negative for HIV. Patients can now receive the injectable drug instead of daily prevention oral medications like Truvada, thanks to the FDA’s approval.

Apretude, on the other hand, necessitates two one-month apart starting injections, followed by two-monthly shots. Apretude was found to be more effective than Truvada at preventing HIV infection in two trials done in 13 countries. Participants who took the injectable medicine following the oral pill cabotegravir were 69 percent less likely to become infected with in a study of over 4,500 cisgender men and transgender women who have sex with men.

The other trial, which included almost 3,200 cisgender women at risk of contracting, found that those who took Apretude with cabotegravir had a 90% lower risk of contracting than those who took Truvada. “Today’s approval adds an important tool to the quest to end the HIV epidemic by giving the first non-daily prevention alternative,” said Debra Birnkrant, director of the FDA’s Center for Drug Evaluation and Research‘s Division of Antivirals.

The FDA expects that the injectable option would increase uptake among high-risk groups, such as young men who have sex with males and those suffering from substance use disorders, depression, or poverty, who are less likely to take their prescription on a regular basis. According to the data of Centers for Disease Control and Prevention, males who have sex with men accounted for 66% of all new HIV diagnoses in 2019.

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