FDA approves first long-lasting HIV drug for PrEP, but there’s a catch

TThe FDA has approved the first injectable drug to protect against the transmission of HIV. Apretude is injected every two months, which distinguishes it from the existing drugs Truvada and Descovy, which are taken orally once a day. It also costs $ 3,700 per dose.

Clinical trials have shown Apretude to be significantly more effective than Truvada in reducing the risk of transmission in cisgender men and transgender women who have sex with men (69%), and especially in cisgender women (90% ).

Daily oral pre-exposure prophylaxis (PrEP) drugs need to be taken consistently enough to be effective, much like a daily oral contraceptive or hepatitis C cure drug. A long-lasting injectable could be revolutionary for some people who have difficulty adhering to a daily medication schedule for a number of reasons including chaotic drug use or not being housed.

“It’s not for everyone” Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, said Filtered. “In our opinion, this is another tool in our toolkit for HIV prevention. Some people may prefer to take medication every day.

For others, the need to successfully communicate with a doctor in person every two months may be too high a threshold. “You have to go to a supplier and get vaccinated,” Schmid said. “Maybe in the future you can go to a mobile clinic or a pharmacy to do it. But you have to have privacy because it’s in your butt.

PrEP drugs block an enzyme that allows the HIV virus to replicate inside the human body. Truvada was approved in 2012 and Descovy was approved specifically for people without vaginal tissue in 2019. Used daily as recommended, they can offer about 99% protection against sexual transmission of HIV and about 80%. % against transmission by injection drug use.

Apretude is not covered by the new requirements of the Biden administration.

In the United States, some of the people most at risk of contracting HIV include trans people and men who have sex with men, particularly if they are black or brown and / or engage in chemsex. People who engage in street sex work are also a recommended priority group for access to PrEP.

The number of people receiving PrEP increased from 2015 to 2020. However, only about a quarter of all people recommended for PrEP in 2020 were actually prescribed it. As HIV clusters increasingly emerge during the pandemic, sustainable and accessible PrEP options have never been more crucial.

A federal program called “Ready, Set, PrEP” covers drug costs for uninsured patients, but does not not cover clinic visits and tests. In July, the Biden administration issued an order requiring almost all insurers to cover the cost of PrEP treatment, including clinic visits and lab tests.

Many private insurers still do not comply with these requirements. Organizations like the HIV + Hepatitis Policy Institute recommend that the federal and state governments monitor and penalize insurers who do not comply.

But Apretude is not covered by the new requirements of the Biden administration. According to Schmid, he cIt would take up to two years for the federal government to force insurers to pay for it.

Photograph by Marco Verch via Flickr / Creative Commons 2.0

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