FDA Approves Long-Acting Injectable to Treat HIV
Monthly regimen can replace daily pills for individuals on treatment with undetectable virus
A long-acting HIV treatment consisting of two shots monthly has been approved by the U.S. Food & Drug Administration (FDA) for adults with suppressed virus currently on a stable antiretroviral regimen.
Cabenuva, which consists of a combination of cabotegravir and rilpivirine administered in two separate shots, is the first FDA-approved injectable, complete regimen given once per month for people with HIV. Patients receive the two shots during the same visit to a physician.
Cabotegravir and rilpivirine are administered in two separate shots. (Photo: Business Wire)
The approval follows clinical trials that demonstrated the new treatment was as effective as the current standard of care: once-daily oral antiretroviral therapy (ART). More than 90% of study participants who were offered to switch to Cabenuva expressed an interest in the monthly injectable over a daily pill.
“We’re encouraged that many people with HIV will now have an option of highly effective monthly shots rather than taking a pill every day,” said Greg Millett, amfAR Vice President and Director of Public Policy. “Still, obstacles remain including high cost and the fact that people with HIV not currently on a stable ART regimen who have unsuppressed virus won’t directly benefit from this news. There is more work to do to help everyone.”
“We’re encouraged that many people with HIV will now have an option of highly effective monthly shots rather than taking a pill every day.”Vocabria, a tablet form of cabotegravir, was also approved by the FDA. The drug is intended for use along with Edurant—oral rilpivirine—for one month prior to starting Cabenuva to ensure the medications are well tolerated.
ViiV Healthcare, which was granted the approvals for Cabenuva and Vocabria, has clinical trial data showing that a once every other month dose of the long-acting injectable is equally effective. The pharmaceutical company is seeking FDA approval for use every two months.
Read amfAR’s series of reports on the critical issues that must be navigated as long-acting antiretrovirals advance toward the market. You can also read our reporting on the long-acting injectable studies HPTN 084 and HPTN 083.