FDA approves first injectable treatment to lower HIV risk
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The Food and Drug Administration on Monday greenlit the first injectable medication for HIV pre-exposure prevention (PrEP).
Why it matters: Debra Birnkrant, director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research, said in a statement approval of Apretude, which reduces the risk of sexually acquired HIV, added an important tool in the effort to end the epidemic "by providing the first option to prevent HIV that does not involve taking a daily pill."
- "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.
- Approval of the drug, made by ViiV Healthcare, which is majority owned by GlaxoSmithKline, comes weeks after the Biden administration announced an updated national strategy on HIV and AIDS with the aim of ending the epidemic by 2030.
Driving the news: Apretude is approved for at-risk adults and teenagers weighing at least 77 pounds.
- The drug is given first as two initiation injections administered one month apart, and then every two months thereafter, according to the FDA.
By the numbers: The FDA conducted two FDA trials examining the safety and efficacy of Apretude.
- They found it reduced the risk of HIV infection by 69% for cisgender men and transgender women who have sex with men compared to daily oral medications.
- That number increased to 90% for cisgender women in the second trial.
The bottom line: "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," ViiV Healthcare’s CEO Deborah Waterhouse 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. With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year."
What they're saying: Kenyon Farrow, managing director of HIV advocacy group PrEP4All, welcomed the FDA's approval but told NBC News he's concerned "implementation of this option will likely take years to make it real for most people."
- "Due to COVID, public health systems are already overburdened and much of the workforce needed to implement this large scale are leaving the field due to burnout," Farrow said.
- "Because it will need to be administered in clinical settings, it won’t be treated as a pharmacy benefit by payers, but instead as a clinical benefit, which will take time to implement the proper coding for billing, as well as education and training for nurses who will likely bear the brunt of the work to implement," Farrow added.
