It’s hoped that long-lasting injectable PrEP will also be approved for use in South Africa
The FDA’s approval of long-acting PrEP that’s injected every two months is a major breakthrough in preventing HIV infection, and should pave the way for its use in South Africa.
The US Food and Drug Administration (FDA) recently announced that it had approved Apretude, an injectable extended-release form of the drug cabotegravir, for use by at-risk adults and adolescents weighing at least 35 kilograms to reduce the risk of sexually acquired HIV.
Apretude is initially given as two initiation injections administered one month apart, and then every two months thereafter.
PrEP (pre-exposure prophylaxis) is the name given to any medication taken before exposure to HIV to avoid infection. It must only be prescribed to individuals confirmed to be HIV-negative.
The daily pill form of PrEP, which is currently available for free for men who have sex with men (MSM), transgender women and other at-risk groups in South Africa, is highly effective, reducing the risk of transmission of HIV by more than 90% if taken correctly.
The practical advantages of the long-lasting injection option is that users do not have to remember to take a pill every day, is more discreet, and shown to be even more effective.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.
“This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” added Debra.
About 1 million people around the world use PrEP pills to prevent HIV infection, many of them gay, bisexual and other MSM. However, PrEP traditionally requires high levels of adherence to be effective.
In the US, certain high-risk individuals and groups, such as young MSM, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence.
Health professionals hope that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.
Now that injectable Apretude is approved for use in the US, it’s expected that it will become available in other countries, including South Africa.
Prof Sinead Delany-Moretlwe, a research professor at the University of the Witwatersrand and Director of Research at Wits RHI, said that the FDA’s announcement “is a tremendous milestone for the HIV prevention field and adds another option for HIV prevention.”
Delany-Moretlwe noted in a statement that it is “also an important signal to other drug regulatory authorities particularly in the African region” and that “a strong FDA recommendation may support in-country reviews and recommendations.”
ViiV Healthcare, the makers of Apretude, have already applied for its approval to regulatory authorities in South Africa, Malawi, Botswana and Zimbabwe.
“We believe that the injectable PrEP offers people a discreet and convenient alternative to daily oral pills for HIV prevention,” said Delany-Moretlwe. “While the FDA announcement is exciting, we are really looking forward to approvals from the regulatory authorities in the African region. We believe that injectable PrEP could significantly impact the trajectory of HIV in our region.”