Apretude, the first injectable HIV prevention drug, gets approved by FDA
The Food and Drug Administration (FDA) has approved Apretude, the first injectable medication for pre-exposure prevention (PrEP) against HIV on Dec. 20.
The new drug, called Apretude, is an injectable given every two months to adults and teens who are at risk of getting HIV through sex who weigh at least 35 kg. It serves as an alternative to PrEP pills taken daily like Truvada and Descovy.
“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,” Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research said in a statement.
"This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
According to the Centers for Disease Control and Prevention, advancements have been made in PrEP use over the past years, but only 25% of the 1.2 million people for whom the medication was recommended were prescribed treatment. It estimated 285,000 people were using PrEP as of 2019, a majority of who are gay and bisexual men.
Clinical trials
The FDA conducted two trials to compare Apretude's safety and efficacy over daily oral medication like Truvada. They found that the new drug was more likely to reduce HIV than the daily pill—69% for cisgender men and transgender women who have sex with men.
ViiV Healthcare CEO Deborah Waterhouse emphasized how the trials "included the largest numbers of transgender women and Black men who have sex with men ever enrolled in HIV prevention."
"People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills," Waterhouse said. "With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year."
The trials also found that Apretude causes side effects including injection site reactions, headaches, fever, fatigue, muscle aches, back pain, and rashes. The approved drug comes with a warning label that it must only be inoculated on confirmed HIV-negative people.
According to the World Health Organization, HIV continues to be a global public health issue, having claimed 36.3 million lives since the 1980s. While there is no cure for HIV infection, access to effective prevention, diagnosis, treatment, and care have been developed over the years.
