The U.S. Food and Drug Administration (FDA) has approved the first-ever injectable pre-exposure prophylaxis (PrEP) drug to prevent HIV transmission.

Known as Apretude, the drug is approved for use in at-risk adults and adolescents weighing at least 77 pounds to reduce their chances of contracting HIV through sexual contact. 

Scientists are calling this new development a game-changer, given that it is not only more effective at reducing the risk of sexually-acquired HIV but is also easier to adhere to. Unlike the current PrEP pills taken daily (Truvada and Descovy), the new treatment only needs to be taken once every two months, after two initiation injections administered one month apart. 

“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 at the FDA, said in a statement.

Adherence to Daily Medication

“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,” Birnkrant added.

The FDA says that in 2020, PrEP was recommended for about 1.2 million people, but only 25% of them received a prescription for the pills. In its statement, the FDA highlighted the challenge of adherence to daily pills, which could be linked to depression, poverty, or other medical disorders. It is hoped that Apretude will thus help make adherence easier and increase PrEP usage.

Two clinical trials comparing Apretude and Truvada found that the injection was more likely to reduce HIV than the daily oral pill. The risk was 69 percent lower for cisgender men and transgender women who have sex with men, while there was a 90 percent less risk for cisgender women.

Participants who took Apretude were at a higher possibility than those who took Truvada to have side effects such as injection site reactions, headache, fever, fatigue, back pain, muscle pain, and rash.

Black Americans 

According to data from the CDC, gay and bisexual men accounted for about 66 percent of new HIV infections in 2019. In terms of race, Black Americans constituted a much larger share of new HIV diagnoses (42%).

“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the U.S., may want options beyond daily oral pills,” Deborah Waterhouse, ViiV Healthcare’s CEO, said in a statement.

“Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial,” she added.

However, it is worth noting that Apretude is only recommended for people confirmed to be HIV-negative immediately before starting the drug intake and before each injection. The FDA warns against using the medication after becoming infected as it could lead to the emergence of drug-resistant HIV variants.