The new drug, Apretude, is administered to patients every two months via injection. Before the approval, there were only two forms of treatment approved as prevention medication for HIV. Truvada and Descovy, both of which are an oral medication that need to be taken once per day.
Apretude is however injected every other month, setting it apart from existing medications Truvada and Descovy, which are taken orally once a day. It also costs $3,700 per dose.
Clinical trials found Apretude significantly more effective than Truvada at lowering risk of transmission among cisgender men and transgender women who have sex with men (69 percent), and especially among cisgender women (90 percent).
Daily oral pre-exposure prophylaxis (PrEP) medications must be taken fairly consistently in order to be effective similar to daily oral birth control, or medication for curing hepatitis C. A long-lasting injectable could be groundbreaking for some people who have difficulty adhering to a daily medication schedule for any number of reasons, including chaotic drug use or being unhoused.
The FDA hopes that approving Apretude is the next step in effectively ending the HIV epidemic.
Apretude is given as two initiation injections administered one month apart, and then given every two months after that. Patients can choose between receiving just Apretude, or they can take the oral medication Vocabria to see how their bodies react to the drug.
According to the U.S. Centers for Disease Control and Prevention, the use of PrEP reduces the risk of getting HIV from sex by 99%, and reduces the risk of infection from injection drug use by at least 74%. However, strict adherence to daily medication is incredibly important in reaping the protective benefits.
PrEP medications block an enzyme that allows the HIV virus to replicate inside the human body. Truvada was approved in 2012, and Descovy approved specifically for people without vaginal tissue in 2019. Used daily as recommended, they can give around 99 percent protection against HIV transmission from sex, and somewhere around 80 percent protection from transmission via injection drug use.