FDA approves first ever injectable PrEP to prevent HIV transmission

A medical professional gives a patient a shot
Photo: Shutterstock

On Monday, the U.S. Food and Drug Administration (FDA) announced it had approved the world’s first injectable treatment to help prevent HIV.

Instead of the daily pills currently required for HIV pre-exposure prophylaxis (PrEP), the new drug, Apretude, first requires two shots one month apart, followed by one shot every two months.

Related: Dr. Anthony Fauci optimistic about experimental HIV vaccine that uses COVID vaccine technology 

Apretude, according to GlaxoSmithKline, the pharmaceutical company behind it, will be more convenient than Truvada, which is the most common form of PrEP currently available and is a daily pill.

The first Apretude trial involved cisgender men and transgender women who have sex with men and compared Apretude to Truvada. Participants using Apretude were 69% less likely to get HIV.

Another trial involving cisgender women found that those taking Apretude were 90% less likely to get HIV than those taking Truvada.

In both trials, participants taking Apretude started by taking a daily pill for up to five weeks before switching to injections.

According to the FDA, those interested in Apretude can either begin injections right away or spend four weeks taking pills to first see how their body reacts to the medication.

Either way, the FDA says Apretude’s success will likely have a positive impact on communities at high risk of HIV infection, giving people another option to prevent HIV transmission.

PrEP is currently recommended for about 1.2 million people considered to be at high enough risk, but as of 2020, only 25% are taking it. This is a significant increase from the 3% who were taking PrEP in 2015, but it still means the majority of at-risk people remain vulnerable.

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

Birnkrant added that the new treatment “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.”

Apretude has been found to have more side effects than Truvada, including fatigue, back pain, rash, headaches, fever, myalgia, and reactions at the injection site.

The FDA also emphasized that patients should only use the drug if they are confirmed HIV negative. Otherwise, they could be at risk of developing drug-resistant HIV.

According to NBC News, Apertude costs $3,700 per dose. Right now, insurers are not required to cover the costs, but almost all companies are currently required by the federal government to cover Truvada.

While Apretude is certainly an exciting addition to the fight against HIV, some activists are not ready to celebrate just yet.

Kenyon Farrow, managing director of the advocacy group PrEP4All, said that Apretude is a welcome development but that the 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,” he 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.”

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