FDA approved the first injectable treatment for HIV/AIDS prevention!
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FDA approved the first injectable treatment for HIV/AIDS prevention!
Another major breakthrough in the history of human medicine!
on December 20th, FDA approved the first injection for pre-exposure prevention of HIV , which is 66% more effective than daily oral drugs!
Patients only need to receive treatment once a month to achieve the effect of suppressing the virus.
This is also a milestone event in the history of HIV treatment, which means the birth of a new and more convenient treatment.
Debra Birnkrant, director of the antiviral division of the FDA’s Center for Drug Evaluation and Research, said:
“Today’s approval adds an important tool to end the spread of HIV and provides the first prevention option that does not require daily medication.”
Drug name: injection drug Aprretude (cabotegravir sustained-release injection)
Instructions:
- After two initial injections with a one-month interval, one injection every two months .
- The boxed warning indicates that it can only be prescribed to HIV-negative people . In undiagnosed HIV patients using Apretude to treat HIV PrEeP, drug-resistant HIV variants have been found. People who are infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. The drug label also includes warnings and preventive measures for hypersensitivity, liver toxicity (liver damage), and depression.
(Screenshot from FDA official website)
For people:
- High-risk adults and adolescents (PrEP) weighing more than 77 pounds (35 kg) who have had a negative HIV test before exposure to the virus.
- Patients can start treatment with Apretude, or take cabotegravir (Vocabria) orally for 4 weeks to assess their tolerance to the drug.
Time to market:
GlaxoSmithKline’s ViiV Healthcare (company headquartered in North Carolina) will begin shipping Apretude to distributors in the United States early next year, the only country that has approved the drug so far.
Other drug options:
Currently, there are oral drugs for HIV prevention , such as Truvada . It is necessary to take oral medication once a day, but it is usually difficult to adhere to.
Test effects:
Two randomized, double-blind trials were conducted in 13 countries to evaluate the safety and effectiveness of Apretude in reducing the risk of HIV infection. These trials compared Apretude injections with Truvada oral medications .
- Test 1: Including men who are not infected with HIV and transgender women with behaviors at high risk of HIV infection.
- Test 2: Including uninfected bisexual women who are at risk of contracting HIV.
According to the FDA, Apretude injection is more effective than Truvada oral medicine in preventing HIV infection .
Overall, the injectable drug is 66% more effective than the daily Truvada oral drug .
In both trials, compared with participants who took Truvada oral medication , participants who took Aprertude had more frequent side effects including injection site reactions, headaches, fever (fever), fatigue, back pain, myalgia, and skin rashes. .
Pre-exposure prevention PrEP therapy requires a high level of compliance to be effective, and certain high-risk individuals and groups, such as young men who have sex with men, are unlikely to adhere to daily medication .
Other interpersonal factors, such as drug use disorder, depression, poverty, and efforts to conceal medication can also affect adherence to medication . The availability of long-acting injectable PrEP will increase the acceptance and adherence of PrEP by these groups.
AIDS status
HIV (Human Immunodeficiency Virus) attacks the body’s immune system . If left untreated, it can lead to AIDS (Acquired Immunodeficiency Syndrome).
The FDA hopes that this injection can be popularized in high-risk groups, such as young men who have sex with men , drug use disorders, depression, and poor people, who are unlikely to insist on taking medication every day.
According to US CDC data, men who have sex with men accounted for 66% of all new HIV cases in 2019 .
CDC data shows that the United States has achieved remarkable results in increasing the use of PrEP to prevent AIDS. Last year, about 25% of 1.2 million eligible people received prescriptions.
In 2015, only 3% of eligible patients received prescriptions, which is a significant improvement. Of course, there is still much room for improvement.
According to CDC data, in 2019 (the most recent year for which data is available), approximately 36,800 new people in the United States were infected with HIV.
Among them, gay men, transgender women and black women are the most severely affected by HIV.
FDA approved the first injectable treatment for HIV/AIDS prevention!
(source:internet, reference only)
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