FDA Approves Injectable PrEP
On Dec. 21, the U.S. Food and Drug Administration (FDA) announced that it approved Apretude, the first injectable treatment for HIV pre-exposure prevention (PrEP), for adults and adolescents weighing more than 77 pounds.
Currently, treatment for adults and adolescents to reduce the risk of sexually acquired HIV is a daily PrEP pill. However, Apretude treatment begins with two injections in the first month and then every two months afterwards.
“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,” FDA Director of the Division of Antivirals, Debra Birnkrant, M.D., said in a statement. She said this treatment will be beneficial to those who are considered high-risk and those who struggle to access or adhere to daily medication.
The U.S. Centers for Disease Control (CDC) published a preliminary report which showed that in 2020, approximately 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed the treatment. This number is a dramatic increase from the three percent in 2015.
“PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence,” the FDA stated in a press release, “It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.”
Read more about the study, Apretude, side effects, etc. in the FDA press release below.