Dec 22, 2021 13:25:00

FDA approves world's first 'injection to prevent HIV infection'

The US Food and Drug Administration (FDA), which has jurisdiction over medical products regulations in the United States, has approved the world's first injection, Apretude, that reduces the risk of being infected with the human immunodeficiency virus (HIV) even before sexual intercourse. Cabotegravir is a type of pre-exposure prophylaxis (PrEP) that is taken before HIV infection and is given twice at 1-month intervals and then at 2-month intervals.

FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention | FDA
https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention

1st long-acting injection to prevent HIV has been approved by the FDA | Live Science
https://www.livescience.com/hiv-prevention-injectable-apretude-fda-approved

FDA Just Approved The World's First Injectable Medication to Prevent HIV
https://www.sciencealert.com/fda-approves-first-long-acting-injection-to-prevent-hiv

On December 20, 2021, local time, the FDA approved cabotegravir, an injectable drug to prevent HIV infection. As an HIV infection preventive drug, there is a tablet type 'Truvada' with a prevention rate of up to 99%, but these should be taken daily. On the other hand, the newly FDA-approved cabotegravir is characterized by less effort, as the first two injections are at 1-month intervals and then at 2-month intervals.

Dr. Debra Brinkland, director of the antiviral drug division at the FDA's Center for Drug Evaluation and Research, said, 'Cabotegravir is an injection given every two months for high-risk individuals and certain people who cannot keep their daily doses. It's an HIV preventative to help. '

According to the FDA, PrEP, which should be taken daily, is recommended in the United States, and by 2020, about 25% of the group at high risk of becoming infected with HIV will be prescribed. However, the FDA seems to have thought that 'there is room for significant improvement.'

Two clinical trials on cabotegravir suggest that cabotegravir can reduce the risk of HIV infection more effectively than Truvada. The clinical trials are conducted as a randomized,

double-blind , 'meeting the gold standard for this type of study,' the FDA notes.

In the first study, subjects also included approximately 4,600 cisgender men and transgender women, and the results of the study showed that those who took cabotegravir were more infected with HIV than those who took Truvada. The risk was 69% lower. In addition, in the second study, approximately 3,200 cisgender females were included, with people taking cabotegravir having a 90% lower risk of HIV transmission than those taking Truvada. rice field.

Subjects who took cabotegravir reportedly showed adverse reactions such as headache, fever, malaise, abdominal pain, myalgia, and rash. The FDA states that you need to weigh at least 77 pounds to take cabotegravir.

Also, when injecting cabotegravir, it is necessary to take an oral preparation called 'Vocabria' 4 weeks before the first injection to check whether it is drug resistant or not. In addition to this, it is also necessary to show a negative HIV test before injecting cabotegravir.

The list price of cabotegravir is $ 3,700 (about 420,000 yen) per dose, and $ 22,200 (about 2.5 million yen) for 6 doses for one year. According to NBC News, it will be sold by American wholesalers and specialists in early 2022.