The FDA approved Apretude (cabotegravir extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) for HIV in December. Administered as an injection every other month, Apretude gives people at risk of contracting HIV a PrEP alternative to taking daily pills.
Despite decades of research, there is still no vaccine against HIV. As a result, pre-exposure prophylaxis (PrEP) has emerged as the most promising preventive strategy against the virus that causes AIDS. PrEP is the use of antiretroviral medications by HIV-negative individuals who are at risk of contracting the disease to reduce that risk.
But the PrEP regimens have involved taking a pill on a daily basis, which makes them ripe for nonadherence.
On Dec. 20, 2021, the FDA approved Apretude (cabotegravir extended-release injectable suspension), the first injectable formulation of PrEP. Instead of daily pills, Apretude will involve getting an injection in the muscle of the buttock by a healthcare professional once every two months, although the first two shots are given a month apart.
“It will not be for everyone; some people may want to continue with a daily oral pill,” notes Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, an advocacy organization funded by several pharmaceutical companies. “They are fairly easy to take and there are limited side effects. People will continue to have to visit their provider for recommended periodic follow up labs and tests.”
Gilead’s PrEP formulation. Truvada (tenofovir disoproxil fumarate and emtricitabine) was approved in 2012. Generic versions have come on the market since, particularly in the past year, and prices have dropped. The GoodRx’s lowest price today a 30-day supply of the most common version of generic Truvada is $35.96. But most people with private insurance do not have to pay cost sharing for PrEP drugs because they have been recommended by the United States Preventive Services Task Force.
Schmid note some people may find it easier to get the injectable every two months.
“They will have to make their own decision, based on discussions with their provider, as to what is best for them,” he says. “Whatever option they choose, it is important for them to adhere to their medication as prescribed and have the periodic HIV, STI (sexually transmitted infection) and other lab tests. While PrEP protects against HIV, it does not protect against other STIs.”
The CDC says that about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it in 2020, compared with about 3% in 2015. The agency credits PrEP and other factors with reducing the new HIV infections: They fell from 37,800 in 2015 to 34,800 in 2019, a decrease of 8%.