FDA approves Cabenuva for HIV.- ViiV Healthcare

ViiV Healthcare announced that the FDA approved Cabenuva (cabotegravir and rilpivirine), as a long-acting regimen for the treatment of HIV-1 in adults. Cabenuva is made up of two injectables, ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.Approval is based on the pivotal phase III ATLAS and FLAIR studies that included more than 1,100 patients from 16 countries. These studies showed that Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly once a month throughout the 48-week study period. In both studies, the most common adverse reactions (Grades 1 to 4) observed in at least 2% of participants were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Serious adverse events occurred in 4% of patients taking Cabenuva, and 3% of adverse events led to withdrawal.