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The U.S. Food & Drug Administration has approved the first injectable HIV prevention drug for adults and adolescents.
Apretude is administered one month apart, then every two months to prevent the risk of acquiring HIV.
The long-acting cabotegravir (or Apretude) injectable drug is approved for at-risk adults and adolescents who weigh at least 77 pounds.
Apretude is not intended for people who are already diagnosed with HIV or AIDS.
READ ALSO: CDC recommends HIV drug PrEP for everyone who is sexually active
The news comes about a month after the Centers for Disease Control updated its guidelines recommending physicians talk to all sexually active adult and adolescent patients about taking PrEP (pre-exposure prophylaxis).
"I really think this puts PrEP in the same place as so many other really good preventive interventions like talking about smoking, alcohol, drugs, etc," Dr. Demetre Daskalakis, the director of CDC's Division of HIV Prevention, told CNN.
The injectable drug is expected to replace the daily PrEP pill for high-risk individuals such as men who have sex with men (MSM).
"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, director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.
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The Centers for Disease Control has updated its guidelines to recommend pre-exposure prophylaxis (PrEP) to all adults and adolescents who are sexually active.
According to the new guidelines, all sexually active adult and adolescent patients should receive information about PrEP.
The new guidance allows primary care doctors to advise patients who are sexually active that the HIV prevention drug PrEP should be a routine part of their care.
PrEP is a drug prescribed to reduce the risk of getting human immunodeficiency virus (HIV) or the virus that causes AIDS.
PrEP reduces the risk of getting HIV from sex by about 99%. Studies determined that only about 25% of adults and adolescents who can benefit from PrEP are actually taking the drug.
"It just makes sense to expand it to everyone," Kristen D. Krause, PD, MPH, tells Health.com. "PrEP is a big tool in the tool kit of HIV prevention."
"Having the CDC give the green light and say that this is an expected and routine part of your care potentially gives license to providers who otherwise might not have had this conversation," Seth Glassman, MD, an infectious disease expert, tells Health.
Before going on PrEP, all patients are required to take an HIV test. People who are already HIV-positive should not take PrEP.
The CDC stresses that PrEP is safe for everyone, and side effects caused by PrEP are mild and resolve eventually.
Those side effects include:
- Stomach pain
"Taking this medication dramatically reduces the chance that you will be infected with HIV if you are exposed to the virus," Jamie Alan, PharmD, PhD, tells Health.
"These side effects should be weighed against the possibility of getting infected with the virus," Alan says.
Frank Ocean is catching heat for promoting his new LGBT+ nightclub by selling $60 t-shirts featuring HIV drug PrEP on the front.
The 31-year-old singer launched his first LGBT+ nightclub in New York City called PrEP+, which is named after the antiviral medication taken by MSM - men who have sex with men - to prevent HIV transmission.
The T-shirts went on sale on Ocean's website following Thursday's launch of the PrEP+ club party Ocean hosted in New York City.
Ocean also promoted the sale of the t-shirts on his Twitter page @blondedocean. "Tee's also come in a black colorway," he tweeted.
Critics took issue with the high cost of the cotton t-shirts: $60. An activist with the New York chapter of Act Up, an HIV/AIDS advocacy group, tweeted Saturday that the shirt's price tag is reminiscent of the steep mark-up of the PrEP drug by pharmaceutical company Truvada.
A $60 tee with "PrEP" on it.
Sounds familiar to a pharmaceutical company that marks up the price of PrEP to over $2,000/month while it costs $6 to make a month supply. This is not it Frank."
The activist also suggested Ocean should donate the proceeds for the shirt to HIV/AIDS advocacy groups such as Act Up.
Coulda also been thoughtful if all the funds went to service providers, PrEP navigators, and HIV justice and treatment orgs, but who asked us?"
Others chimed in, asking Ocean if he planned to donate the proceeds to companies that give out PrEP for free.
frank ocean selling shirts that say prep on them for $60 like ummmmm are you using the profits to donate to orgs that give out prep for free???? bc otherwise yikes my dude!"
Another Twitter user wrote:
"But sure, let's have Frank Ocean use a pill millions can't afford to promo new music at a fake queer party and to sell $65 shirts".
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