Apretude is the name of the new drug that will be an alternative to daily pills for HIV prevention.
The world’s first injectable drug to reduce the risk of contracting HIV has been approved by the Food and Drug Administration (FDA).
The injectable drug, called Apretude is an extended-release injectable suspension of cabotegravir, provides an alternative to daily HIV prevention pills, such as Truvada and Descovy. These pills are up to 99% effective in preventing sexual transmission of HIV, but must be taken every day to be as effective, according to the Centers for Disease Control and Prevention (CDC).
In contrast, to start with Apretude, individuals initially receive two injections, spaced one month apart, and then receive one injection every two months thereafter.
The FDA expects that the availability of a long-acting injectable HIV prevention drug will increase the uptake of such drugs in high-risk groups.
Pre-exposure prophylaxis (PrEP), i.e., medications taken to prevent HIV, is recommended for approximately 1.2 million people in the USA, and in 2020, about 25% of those people received a prescription for PrEP pills.
Two clinical trials suggest that Apretude reduces the risk of HIV infection more effectively than the daily pill Truvada. The trials met the standard for this type of study because they were randomized and double-blinded, meaning that those who received the actual medication were randomly selected and neither the doctors nor the patients knew who was receiving the actual medication rather than the placebo.
Trial participants taking Apretude experienced more side effects than those taking Truvada, including headaches, fever, fatigue, back pain, myalgia, rash and injection site reactions.
As of Dec. 20, Apretude has been approved for use in at-risk adults and adolescents weighing at least 35 kilograms. Patients have the option of taking an oral formulation of cabotegravir, called Vocabria, daily for four weeks before starting injections to see how well they tolerate the drug.
Patients should be tested for HIV and confirmed negative before starting Apretude and should be confirmed negative before each injection to avoid the risk of developing drug-resistant HIV.
“Drug-resistant HIV-1 variants have been identified with the use of Apretude for HIV-1 PrEP by persons with undiagnosed HIV-1 infection.”
Individuals who become infected with HIV-1 while receiving Apretude for PrEP should transition to a full HIV-1 treatment regimen.
ViiV Healthcare
Apretude has a list price of $3,700 per dose (about €3,270) and is expected to ship to wholesalers and specialty distributors in the US.