The very first, long-acting injectable medication for use as Pre-Exposure Prevention (PrEP) against the HIV virus has been approved by the Food and Drug Administration (FDA) on Monday. This new drug called Apretude, is an injectable that must be administered every 2 months as an alternative to pills, such as Descovy and Truvada, which have been found to lower the risk of HIV by 99% when consumed on a daily basis.
Two FDA trials meant to evaluate the safety and efficacy of this drug, arrived at the conclusion that Apretude is more likely to lower HIV in comparison to the aforementioned daily pills – by 90% cisgender women, and 69% for transgender women and cisgender men who have sex with men.
Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, stated that this approval now includes a crucial tool in the arsenal to end the HIV epidemic by providing the first option that doesn’t involve daily pills to prevent HIV. This drug will be crucial in combatting the HIV epidemic in the U.S., and even help high-risk individuals as well as certain individuals who are unable to adhere to the daily medication routine.
While tremendous strides have been made in the use of these forms of medication over the past few years, according to the Centers for Disease Control and Prevention (CDC), only a mere 25% of the 1.2 million individuals whom these medications were recommended for, were actually prescribed these orally consumable drugs (2019).
As per data from the CDC, in the U.S. in 2019, it was concluded that 66% of all new diagnoses were attributed to men who had sex with other men. Delving further into the statistics of the survey on the basis of race, Black Americans were found to account for about 42% of all new diagnoses that year. Earlier in July this year, the federal government that a majority of insurers must cover the 2 forms of approved pre-exposure prevention drugs – Descovy and Truvada, however, insurers will not be liable to cover all costs for this new injectable drug, which is presently listed at US$ 3,700 per dose, with shipping expected to specialty distributors and wholesalers commence in the U.S., in early 2022.