Health
FDA approves first injectable PrEP drug to reduce HIV risk
Apretude is at risk of transmitting HIV through sex and is approved for adults and teens weighing 77 pounds or more. Initially given 2 shots at 1-month intervals, then every 2 months.
PrEP was previously only available in the form of pills, Truvada and Descovy.
“Today’s approval adds an important tool for ending the HIV epidemic by providing the first option for HIV prevention without taking daily tablets,” said the FDA’s Antiviral Center. Dr. Debra Birnkrant, Director, said. Drug evaluation and research.
New drug approval is “important for combating the HIV epidemic in the United States and assists high-risk individuals and certain groups where daily medication compliance is a major challenge or not a viable option. Including doing, “Birnkrant added.
In 2019, an estimated 34,800 new cases of HIV were diagnosed. This is the latest year for which federal statistics are available. This is down from 37,800 in 2015. According to data from the US Centers for Disease Control and Prevention, PrEP was recommended to about 1.2 million people in 2020, but only one-quarter was prescribed.
The FDA found in two double-blind clinical trials comparing Apretude and Truvada that people who received injections had a significantly lower risk of HIV. The risk was 69% lower in the first trial of HIV-negative cisgender men and transgender women having sex with men and 90% lower in the second trial involving cisgender females.
Studies have shown that appletude is more likely to cause side effects such as injection site reactions, headaches, malaise, back pain, myalgia, and rashes than torubada.
Due to the risk of drug-resistant HIV mutations, Apretude is intended only for people who test negative for HIV immediately before starting the drug and before each injection. The label also includes warnings about hypersensitivity reactions, liver damage, and depressive disorders.
Amanda Seeley of CNN contributed to this report.
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