A long-acting HIV prevention medication that’s even easier than daily PrEP could be available as early as next year.
Last Thursday, as industry publication Fierce Pharma reported, the U.S. Food and Drug Administration granted priority review status to cabotegravir, a long-acting version of pre-exposure prophylaxis (PrEP) made by the pharmaceutical company ViiV Healthcare, which is majority-owned by GlaxoSmithKline. The drug will now undergo a shortened six-month review period rather than the standard 10-month period.
The FDA could issue its decision on the drug, commercially known as Cabenuva, as early as January of next year, as Fierce Pharma noted. If cabotegravir passes priority review, it would become the first available medication of its kind.
Rather than adhering to a daily regimen of pills, as is the case with oral PrEP, patients would be able to receive an injection every other month to prevent contracting HIV.
The good news follows a year of delays for ViiV Healthcare due to manufacturing problems after the FDA initially approved cabotegravir last November. Late-stage clinical trials of men who have sex with men, transgender women, and cisgender women have boosted “optimism” for the drug, Fierce Pharma observed, with data showing that the drug was more effective than Truvada, the most widely available form of oral PrEP.
A large May study from GlaxoSmithKline, which included more than 4,500 cis men who have sex with men and trans women who have sex with men, found that cabotegravir was safe and that it was more effective than Truvada in preventing HIV infections, although it was unclear whether the drug was as effective at preventing intravenous infection.
At the time, Shannon Hader, the Deputy Executive Director of the Joint United Nations Program on HIV/AIDS, called the study a “breakthrough that will have a significant impact on the lives of gay men and other men who have sex with men and transgender women when they are at higher risk of HIV infection.”
In a statement to Fierce Pharma, ViiV research and development chief Kim Smith noted that only about a quarter of people in the United States “who could benefit from PrEP are currently taking it,” adding that “new options like investigational cabotegravir will help play a significant role in our collective efforts to end the HIV epidemic.”
Long-acting forms of PrEP could help reduce HIV transmission as pharmaceutical companies continue to develop vaccines against the virus. Moderna’s HIV vaccine, which uses similar mRNA technology to the company’s COVID-19 vaccine, has been in clinical trials since August, with an end date expected sometime in spring 2023.
However, it’s unclear whether GlaxoSmithKline or Moderna will address the number one barrier to access for people seeking HIV prevention treatments: cost.
Although the Centers for Disease Control and Prevention recently mandated that insurance companies cover out of cost pockets for PrEP, including clinic visits and regular lab fees, both Truvada and Descovy, which are manufactured by Gilead, are priced at nearly $2,000 a month out of pocket.
These high costs left uninsured people with few options until very recently; in May, several generic versions of PrEP became available after Truvada’s FDA exclusivity expired, which has driven the price of the drug down as a whole.
The financial inaccessibility of PrEP has had particularly devastating implications for Black and Latinx people, including cis Black women, trans women, and injection drug users, according to the CDC.
Although expanded options for HIV prevention are exciting scientific developments, advocates continue to maintain that high out-of-pocket costs and other systemic barriers to treatment must be addressed in order to end the epidemic once and for all.
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