First Injectable HIV Prevention Drug Approved by FDA

FDA announced Monday that the first injectable long-acting medicine to prevent HIV pre-exposure has been approved.

As an alternative to HIV prevention pills like Truvada and Descovy, which are shown to reduce the risk of HIV by 99 percent, Apretude an injectable given every two months.

Apretude was found to be more likely than daily oral medications to reduce HIV in cisgender men and transgender women who have sex with men — by 69 percent for cisgender men and transgender women who have sex with men and by 90 percent for cisgender women in two FDA trials analyzing the drug’s safety and efficacy.

Apretude’s improved efficacy was attributed to the ease with which trial participants followed the every-other-month routine vs taking a pill every day.

“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, the director of antivirals division at 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.”

Despite improvements in PrEP use over the past several years, the Centers for Disease Control and Prevention reports that only 25 percent of the 1.2 million people for whom PrEP is recommended received the treatment last year.

According to the CDC, as of 2019, there were approximately 285,000 people using PrEP, the majority of whom were gay or bisexual males.

As a result of the newly approved long-acting injectable from ViiV Healthcare, which is majority-owned by GlaxoSmithKline, the HIV rate is expected to drop in the United States.

“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,” Deborah Waterhouse, ViiV Healthcare’s CEO, said in a statement, adding that “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.”

The CDC reported that men who have sex with men accounted for 66 percent of all new HIV diagnoses in the U.S. in 2019. When the numbers were broken down by race, Black Americans accounted for 42 percent of all new diagnoses.

The federal government declared in July that almost all insurance must cover the two approved kinds of PrEP medications, Truvada and Descovy, as well as the lab tests and clinic visits required to keep such prescriptions – with no copays.

Currently, insurers are not required to cover all expenses associated with the new injectable version of PrEP, which has a list price of $3,700 per dosage and is expected to start shipping to wholesalers and specialty distributors in the United States in early 2022.

Kenyon Farrow, the managing director of PrEP4All, said his organization is “definitely happy to see the FDA approval of another option for people who want to use PrEP.”

However, he said he fears that the “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,” he said in an email. “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.”