First injectable HIV prevention drug gets FDA approval
The US Food and Drug Administration (FDA) has approved the first injectable prevention medication for HIV, offering an alternative to pre-exposure preventative tablets.
The new drug, Apretude, is administered to patients every two months via injection. In contrast, pills already on the market can prevent the risk of contracting HIV by 99% if taken daily.
“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,” Dr. Debra Birnkrant, director of the antivirals division at the FDA’s Center for Drug Evaluation and Research, said in Monday’s announcement.
Health officials have warned daily pills can be a regimen that is difficult for some to stick to, making injections a more viable option to at-risk populations, and potentially increasing those taking prevention medication.
The approval comes after two FDA trials found Apretude was more effective in reducing risk to HIV than daily pills for 69% of “cisgender men and transgender women who have sex with men” and 90% of “cisgender women.”
Great news! @US_FDA approves long-acting cabotegravir injections -- brand name Apretude -- for #HIV prevention. More options will hopefully mean more people at risk for HIV will start and stay on #PrEP. @pozmagazine@ViiVUS@ViiVHChttps://t.co/1sMj4FIQN5— Liz Highleyman (@LizHighleyman) December 20, 2021
Adherence is a problem for at-risk people who are poor, depressed & who face stigma, so FDA recommends that cabotegravir #PrEP be targeted to these groups.But I've talked with lot of people in these communities who say researchers are short-sighted. eg https://t.co/FTljqop195— Amy Maxmen, PhD (@amymaxmen) December 20, 2021
The FDA ultimately found the injection to be 66% more effective in preventing HIV infections than a daily dose of Truvada, a leading HIV prevention drug. The two trials, taken across 13 countries, included one studying more than 4,500 “HIV-uninfected men and transgender women who have sex with men”, and the other including over 3,000 “uninfected cisgender women at risk of acquiring HIV.”
Apretude, which is a form of GlaxoSmithKline’s cabotegravir drug, has been approved for at-risk adults and adolescents in the US. It is initially given in two doses, administered one month apart, and then injections are given once every two months. The drug is only to be used by patients with confirmed HIV-negative tests.
Apretude will begin shipping to distributors next year. The FDA noted that preliminary data shows that in 2020, approximately 25% of the 1.2 million people recommended for pre-exposure HIV prevention were actually prescribed medication.