The FDA approved the world's first injection to reduce the risk of acquiring HIV.
The drug Apretude is an alternative to daily pills for HIV prevention. According to the CDC, these pills are effective at preventing the sexual transmission of HIV, but must be taken every day to be that effective.
To start Apretude, people receive two shots, one month apart, and then they receive an injection every two months, according to the FDA statement.
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"This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option."
The FDA hopes that the availability of a long-acting drug for HIV prevention will increase the use of such drugs in high-risk groups.
About 1.2 million people in the US are recommended to take pre-exposure prophylactics, orPrEP, to prevent HIV, and 25 percent of them received a prescription in 2020. The statement says that there is still room for improvement.
Two trials show that Apretude reduces the risk of HIV more than Truvada. The trials met the gold standard for these types of studies because they were randomized and double-blind, meaning the patients and doctors didn't know who was getting the real medication.
The first trial included 4,600 cisgender men and trans women who have sex with men. Participants who took Truvada had a lower risk of getting HIV than those who took Apretude.
The second trial found that people who took Apretude had a 90 percent lower risk of getting HIV than people who took Truvada.
According to the statement, the trial participants who took Apretude experienced more side effects than the Truvada participants.
The FDA approved Apretude for use in at-risk adults and adolescents weighing at least 77 pounds. Patients have the option to take an oral form of cabotegravir for four weeks prior to starting the injections to see how well they tolerate the drug.
Patients should be tested for HIV before starting Apretude and should be negative before each injection to avoid the risk of developing drug-resistant HIV.
According to a statement from the drug's manufacturer, the drug's use has been identified with drug-resistant HIV-1 variants.
Individuals who become HIV-1 positive while receiving Apretude forPrEP must transition to a complete HIV-1 treatment regimen.
The CDC updated its guidance on how doctors should inform patients about pre-exposure prophylactics. The agency now recommends that health care providers inform all sexually active adults and adolescents about the benefits of pre-exposure prophylactics, regardless of whether they report certain behaviors that would put them at high risk of HIV exposure. There are a number of possible options that can be presented to these patients.
The price for a single dose of Apretude is US$3,700 and is expected to ship to US distributors early next year, according to NBC News.
In July, the federal government mandated that most US insurance companies must cover Truvada and Descovy, as well as the lab tests and clinic visits needed to maintain the prescriptions, with no cost sharing; but as of yet, insurers are not required to cover all the costs of taking A
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The article was published by Live Science. The original article can be found here.
