FDA Approves Injectable PrEP

NEW HIV PREVENTION WEAPON INJECTABLE PREP

Damon Scott

The U.S. Food and Drug Administration (FDA) last month approved the firstever injectable PrEP (pre-exposure prophylaxis) to prevent HIV transmission: Apretude.

PrEP is typically taken orally each day as a pill; its most common forms are Truvada and its more recent cousin Descovy. Apretude first requires two shots one month apart, and then one shot every two months.

“Just as with oral PrEP, regimens to prevent HIV do not require as much potency as HIV treatment regimens,” Stephen J. Fallon, executive director of Latinos Salud in Wilton Manors, said. “It’s easier to block HIV from getting in than it is to chase HIV around the body once it’s already in.”

Fallon said Latinos Salud plans to offer its patients any PrEP option that becomes available.

“The only limitations that come may be insurance companies’ formularies or denials from patient assistance programs,” he said. “Typically, our staff finds a way to get our patients the form of PrEP they choose.”

Latinos Salud and other organizations spend considerable time and resources on HIV prevention methods as South Florida consistently has one of the highest rate of HIV diagnoses in the country. The state had the highest rates in 2020.

“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,” Debra Birnkrant, director of the Division of Antivirals at the FDA’s Center for Drug Evaluation and Research, said in a news release.

Birnkrant said Apretude “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 a report by LGBTQ Nation, PrEP is currently recommended for about 1.2 million people who are considered at high risk, but as of 2020, only 25% were taking it. While it’s a big increase from the 3% who were taking PrEP in 2015, it still means that most of the at-risk population remains vulnerable.

Photo via Adobe.

The pharmaceutical company behind Apretude is GlaxoSmithKline. It conducted an initial Apretude trial that involved cisgender men and transgender women who have sex with men and compared Apretude to Truvada. Those using Apretude were 69% less likely to get HIV. An additional trial involving cisgender women found that those taking Apretude were 90% less likely to get HIV than those taking Truvada.

Meanwhile, NBC News recently reported that Apretude currently costs $3,700 per dose. Insurers currently are not required to cover the costs, but virtually all companies are required by the federal government to cover Truvada.

Kenyon Farrow, managing director of the advocacy group PrEP4All, told LGBTQ Nation that Apretude is a positive development but that its implementation will be difficult and could take years to reach 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.”