The Food and Drug Administration has approved the first injectable, long-acting form of PrEP (pre-exposure prophylaxis) to reduce the risk of sexually-transmitted HIV. It’s the first option to prevent HIV that doesn’t require taking a daily pill like Truvada or Descovy.
After two initial injections one month apart, Apretude is administered every two months, according to a statement by the FDA.
The hope is that those in high-risk groups, like men who have sex with men, will have better adherence to taking an injectable form of PrEP every two months versus staying on a daily pill regimen.
According to the CDC, men who have sex with men accounted for 66% of all new HIV diagnoses in the U.S. in 2019. Black Americans made up the largest demographic representing 42% of all new infections that year.
Federal statistics show an estimated 34,800 new cases of HIV were diagnosed in 2019, the latest year for which data is available. That represents a downward trend from 37,800 in 2015.
Today we approved the first injectable treatment for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prevention to reduce the risk of sexually acquired HIV. https://t.co/TBU7pU6gOo pic.twitter.com/mnGkYt4xoM
— U.S. FDA (@US_FDA) December 20, 2021
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,”
The Centers for Disease Control and Prevention report that in 2020, about one in four of the 1.2 million people for whom PrEP is recommended were prescribed it.
Two separate large-scale double-blind clinical trials comparing Apretude to Truvada found the injectable to be more effective at preventing HIV infection from sex than the oral medication.
Trial 1 involved 4,566 uninfected men and transgender women who have sex with men. Those who took Apretude had 69% less risk of getting infected compared with participants who took Truvada, according to the FDAhttps://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention.
Trial 2 included 3,224 cisgender women at risk of HIV infection. The women who took Apretude had a 90% less risk of being infected by HIV.
JUST IN: FDA approves the first long-acting injectable medication for use as pre-exposure prevention against HIV. https://t.co/tU6whvqJj8
— NBC Out (@NBCOUT) December 21, 2021
The trials were were inclusive of Black and Latino men and transgender women who are disproportionately affected by HIV.
The drug’s manufacturer is ViiV Healthcare, an HIV-focused pharmaceutical company owned by the British pharmaceutical giant GlaxoSmithKline.
While the U.S. is the first country to approve the treatment, Viiv has requested approval in additional countries including Australia, South Africa and Zimbabwe.
The federal government announced in July that nearly all insurers must cover the two approved forms of PrEP pills, Truvada and Descovy, including any lab tests and office visits. At this time, however, insurers will not be required to cover costs for the Apretude, which has a list price of $3,700 per dose. The treatment is expected to begin shipping in the U.S. in early 2022.