The FDA has approved the first injection regimen for HIV prevention

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Authors: Robert Preidt and Robin Foster
HealthDay reporters

TUESDAY, December 21, 2021 (HealthDay News) – First injectable drug to prevent HIV the infection was approved by the U.S. Food and Drug Administration on Monday.

“Today’s approval adds an important tool in an effort to end the HIV epidemic by providing the first option for HIV prevention that does not involve taking a daily pill,” said Dr. Debra Birnkrant, Director of Antiviral Drugs at the FDA Drug Center. research, it is said in an agency statement.

Apretude (cabotegravir), manufactured by ViiV Healthcare, is approved for use in high-risk adults and adolescents weighing at least 77 pounds to reduce their risk of HIV. It is first given as two injections one month apart and then one injection is given every two months thereafter.

Experts welcomed the news.

“This is revolutionary. This is changing the game. This is revolutionary,” said Dr. David Rosenthal, medical director of the HIV Center for Young Adults, Adolescents and Children at Northwell Health, Great Neck, NY. HIV prevention through two injections every two months, the whole realm of possibilities opens up. “

IN company news release announcing the approval, Viiv CEO Deborah Waterhouse said: “People who are vulnerable to acquiring HIV, especially those in black and Latino communities who are disproportionately affected in the US, may want options other than daily oral pills. With Apretude, people can reduce their risk of getting HIV with just six injections a year. ”

So far, there are two types of daily pills (Truvada and Descovy) were the only options for what is called pre-exposure prophylaxis (PrEP), but adhering to these daily HIV prevention medications can be difficult, the FDA notes.

Rosenthal agreed. “We know that only 25% of those who would benefit from HIV prevention with prophylaxis before exposure [PrEP] they are currently taking it, ”he noted.“ Often this is because patients do not want to take medication on a daily basis. We still see cases of HIV in the group 25-39 years ago, and PrEP is one of the great tools we have to help people be safe and allow them to take control of their sex lives. “

FDA approval for Apretude is based on two Clinical trials comparing injectable drug with Truvada. The first study included men without HIV and transgender person women who have sex with men and have high-risk behaviors for HIV infection, while another study included women without HIV at risk for HIV infection.

In the first study, those taking Apretude had a 69% lower risk of HIV infection than those taking Truvada. In another study, those taking Apretude had a 90% lower risk of HIV infection than those taking Truvada, according to the FDA.

Participants taking Apretude were more likely than those taking Truvada to have side effects such as injection site reactions, headache, fever, fatigue, back pain, muscle pain and rash.

Patients who want to take Apretude can first take cabotegravir as a pill for four weeks to assess how well they tolerate the drug, the FDA said.

Apretude carries a warning in the box that the drug should not be used unless a negative HIV test is confirmed.

“This injection, given every two months, will be critical to tackling the U.S. HIV epidemic, including helping high-risk individuals and certain groups where adherence to daily medications has been a major challenge or not a realistic option,” he said. Birnkrant.

However, price could be an issue for downloading Apretude.

In July, the American Center for Medicare and Medicaid Services announced that almost all insurers must cover two approved forms of PrEP pills, Truvada and Descovy, as well as laboratory tests and clinic visits required to maintain such prescriptions. As it stands now, insurers will not have to cover all costs for Apretude, whose catalog price is $ 3,700 per dose, NBC News reported.

More information

Visit U.S. Centers for Disease Control and Prevention for more information HIV / AIDS.

SOURCE: U.S. Food and Drug Administration, press release, December 21, 2021; ViiV Healthcare, press release, December 20, 2021; NBC News

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