Health Canada approves Cabenuva for HIV.- ViiV Healthcare

Health Canada has approved Cabenuva (cabotegravir and rilpivirine extended-release injectable suspensions), from ViiV Healthcare, the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]). Vocabria (cabotegravir oral tablets), to be used for short time periods in conjunction with Cabenuva, have also been approved by Health Canada. These approvals are the first for Cabenuva and Vocabria anywhere in the world.The approval of Cabenuva is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 participants from 16 countries. Prior to initiating treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine lead-in was administered for approximately one month to assess the tolerability of cabotegravir and rilpivirine. The studies demonstrated that Cabenuva, when injected intramuscularly in the buttocks, once a month, was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression 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 receiving Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhoea. Over the 48-week study period, a total of 4% of participants discontinued Cabenuva due to adverse events. The New England Journal of Medicine published the 48-week results of these studies in its March 4, 2020 issue.