The US Food and Drugs Administration (FDA) on Monday, 20 December, green lit Apretude, an injectable HIV prevention drug for pre-exposure prophylaxis (PrEP).
PrEP is typically given as a course of oral pills to at-risk individuals before exposure, but this is the first injectable kind.
“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, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research in a statement released by the US FDA on Friday.
About the Injectables
According to a statement released by the US FDA, Apretude is a cabotegravir extended-release injectable suspension for use in people at risk of getting infected with sexually transmitted HIV.
It is a preventive treatment meant for adults and adolescents. However, the person must weigh over 35 kilograms.
The course involves taking two initial injections one month apart, and then one shot every two months.
Two randomised, double-blind clinical trials were conducted to compare the efficacy of Apretude with Truvada—a once daily oral medication for HIV PrEP.
The trials involved uninfected cis men, transgender women, and cis women who have sex with men and are at risk of acquiring HIV.
Trial 1 that involved 1, 4,566 cis men and transwomen showed participants who took Apretude had 69 percent less risk of getting infected with HIV when compared to participants who took Truvada (oral pills for HIV PrEP meant to be taken daily).
On the other hand, Apretude was found to reduce the risk of infection by 90 percent in participants in Trial 2 which involved 2, 3,224 cisgender women.
How Is It Different From the PrEP Pills?
Although the US FDA acknowledges the strides made in HIV prevention with the revolutionary PrEP, they also admit that there is room for improvement. This is where Apretude comes in, and can prove to be a game changer.
The one shortcoming of the previous PrEP treatments is that it involved a daily dose of oral pills that needed to be adhered to strictly for it to work.
Apretude makes the whole process a bit less hassle some as one only needs to get the shot once in two months.
"It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups," said the US FDA in their 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."Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research
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