The world’s first injectable drug to reduce the risk of transmitting HIV is approved by the Food and Drug Administration (FDA). Announced by the agency Monday (December 20th).
An injectable drug called Appletude or its generic name “Cabotegravir Suspension for Suspended Injection” provides a daily tablet replacement. HIV Prevention such as Truvada and Descovy. These drugs are up to 99% effective in preventing sexually transmitted HIV, but you should take them daily to be effective. Centers for Disease Control and Prevention (CDC).
In contrast, to start Apretude, people first receive two shots at monthly intervals and then every two months. FDA statement..
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“This injection, given every two months, is HIV in the United States, including helping high-risk individuals and certain groups where compliance with daily medications is a major challenge or not a viable option. It’s important to combat the epidemic, “Birnkrant, director of the antiviral drug division at the FDA’s Center for Drug Evaluation and Research, said in a statement.
The FDA hopes that the availability of long-acting injections for HIV prophylaxis will increase the intake of such drugs in high-risk groups, the statement said. In the United States, pre-exposure prophylaxis (PrEP), which means medications taken to prevent HIV, is recommended, and by 2020, about 25% of these individuals were prescribed PrEP pills. This is up from just 3% in 2015, but “there is still room for significant improvement,” the statement said.
Two clinical trials suggest that Apretude reduces the risk of HIV infection more effectively than the daily pill Truvada. The trial was randomized and double-blind and therefore met the gold standard for these types of studies. That is, the people who actually took the medication were randomly selected, and neither the doctor nor the patient knew who was actually taking the medication than the placebo.
The first trial was with nearly 4,600 cisgender men Transgender Females having sex with men, Live science previously reported.. Those who took Apretude had a 69% lower risk of becoming infected with HIV than those who took Truvada. According to an FDA statement, in a second study of approximately 3,200 cisgender women at risk of becoming infected with HIV, those who took Appletude compared to those who took Tolvada. We found that the risk of getting HIV was 90% lower.
According to the statement, study participants who took Appletude experienced more side effects than those who took Tolvada, including headache, fever, malaise, back pain, myalgia, rash, and reaction at the injection site. ..
As of December 20, Apretude has been approved to weigh at least 77 pounds (35 kilograms) of at-risk adults and adolescents, according to an FDA statement. Patients can take an oral preparation of cabotegravir called bocabria daily for 4 weeks before starting the injection to confirm resistance to the drug. To avoid the risk of developing drug-resistant HIV, patients should be tested for HIV and tested negative before starting Apretude and tested negative before each injection.
“Drug-resistant HIV-1 mutants have been identified by using Apretude for HIV-1 PrEP in individuals with undiagnosed HIV-1 infections.” Statement from a pharmaceutical company, ViiV Healthcare. “Individuals infected with HIV-1 while undergoing PrEP Apretude should move to a complete HIV-1 treatment regimen.”
Earlier this month, the CDC updated its guidance on how doctors can notify patients about PrEP. Hill reported.. Currently, healthcare providers inform all sexually active adults and adolescents about PrEP and administer the drug to anyone seeking them, regardless of whether they report specific behaviors at high risk of HIV exposure. We recommend that you provide it. Apretude has joined the list of options that may be offered to these patients.
Apretude is priced at $ 3,700 each ($ 22,200 per year for six) and will be shipped to US wholesalers and specialists early next year. NBC News reported.. In July, the federal government mandated that most US insurers, in addition to Truvada and Descovy, need to cover the lab tests and clinic visits needed to maintain their prescriptions at no cost. But for now, insurance companies don’t have to bear all the costs of taking Apretude.
Originally published on Live Science.
The first long-acting injection to prevent HIV has been approved by the FDA
https://www.livescience.com/hiv-prevention-injectable-apretude-fda-approved The first long-acting injection to prevent HIV has been approved by the FDA