The US Food and Drug Administration (FDA) has approved ViiV Healthcare and Janssen’s long-acting regimen for HIV-1 infection Cabenuva (cabotegravir, rilpivirine).
Cabenuva consists of two injectable medicines – ViiV’s cabotegravir and Janssen’s rilpivirine – and is dosed once monthly.
It is an additional option to replace the current antiretroviral (ARV) regimen in people who are virologically suppressed on a stable regimen, with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine.
The approval is based on the Phase III ATLAS studies which included more than 1,1000 patients from 16 countries.
In these studies, Cabenuva was found to be as effective in maintaining viral suppression as continuing a daily oral three-drug regimen.
In addition, Cabenuva was preferred by nine out of ten patients over their previous daily oral therapy in these studies.
“Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year,” said Lynn baxter, head of North America, ViiV Healthcare.
“At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission,” she added.