ViiV Healthcare Announces Availability of CABENUVA and VOCABRIA in Canada
LAVAL, QC, Sept. 23, 2020 /CNW/ - Today, ViiV Healthcare Canada announced stock availability of CABENUVA and VOCABRIA across the country. CABENUVA is the first and only once-monthly, complete long-acting injectable regimen indicated 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/mL). It combines the integrase strand transfer inhibitor (INSTI) cabotegravir with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.1 [VOCABRIA and CABENUVA PM p4A,26A]
Both CABENUVA and VOCABRIA received approval from Health Canada on March 18, 2020. VOCABRIA, oral cabotegravir, together with Janssen Pharmaceutical Companies of Johnson & Johnson's EDURANT, oral rilpivirine, is used for the short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed prior to initiating CABENUVA.1 [VOCABRIA and CABENUVA PM p4A]
Dacia Hibbert, General Manager of ViiV Healthcare Canada, said: "We are proud to make CABENUVA and VOCABRIA available to people living with HIV. CABENUVA will give people living with HIV the option of maintaining viral suppression with 12 treatments per year."
The approval of VOCABRIA and CABENUVA was 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, including Canada. Prior to initiating treatment with CABENUVA, oral dosing of VOCABRIA and EDURANT 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 effective in maintaining viral suppression throughout the 48-week study period.1-3 [VOCABRIA and CABENUVA PM p35A,35B,37B,38A][Swindells 2020 p4A,5A][Orkin 2020 p4A,5A]
In both studies, the most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhea. Over the 48-week study period, a total of 4% of participants discontinued CABENUVA due to adverse events.1 [CABENUVA PM p.16A,16B]
Please consult the Product Monograph at www.viivhealthcare.ca for complete safety information. The Product Monograph is also available by calling 1-877-393-8448.
About ViiV Healthcare
For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
SOURCE ViiV Healthcare
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