America's FDA approves injectable PrEP treatment

Patients would eventually be given an injection every two months.


Words: Alastair James; pictures: Pexels

The US' Food and Drug Administration (FDA) has approved injectable PrEP treatment for those who are at risk of catching HIV in a step that could help reduce HIV transmission in the US.

The FDA made the announcement on Monday (20 December) that the new treatment, which would eventually see patients take an injection every two months rather than a daily pill, would be for those deemed at high-risk and those weighing 35Kg (77 pounds).

Initially, Apretude would be given as two initial injections administered one month apart, and then every two months after that.

"An important tool in the effort to end the HIV epidemic"

Debra Birnkrant, the M.D., director of the Division of Antivirals of the FDA’s Center for Drug Evaluation and Research says the 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."

Data from the U.S. Centers for Disease Control and Prevention shows that of the 1.2 million people who were recommended PrEP in 2020, only about 25 percent were prescribed it.

In 2015 the figure was only 3 percent. The FDA is concerned with adherence to regular medication, so hopes this long-acting injectable option is a solution. 

In trials, the effectiveness of Apretude was compared to one of the PrEP pills, Truvada.

Researchers found in the first trial, which looked at cisgender men and transgender women who have sex with men that those taking Apretude were 69 percent less likely to be infected with HIV compared to Truvada.

In the second trial of cisgender women, those who took Apretude had 90% less risk of getting infected with HIV

Some side effects of Apretude were noted by the FDA including injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.

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