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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 copiesmL). It combines the integrase strand transfer inhibitor (INSTI)Â 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 HIV
At the end of 2016, there were an estimated 63,110 people living with HIV in Canada , representing a 5% increase from 2014. The HIV prevalence rate was 173 per 100,000 population with an estimated 14% of people unaware of their status. As treatments work to reduce HIV-related mortality, and new infections are outpacing the number of deaths, the number of Canadians living with HIV will likely continue to increase in the near future. 4 [PHAC 2016 p8A,9A]
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012 . The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com .
About GSK
GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.ca.gsk.com .
References:
1. ViiV Healthcare ULC. VOCABRIA and CABENUVA Product Monograph. March 18, 2020 .
2. Swindells S et al. N Engl J Med 2020;382:1112-23.
3. Orkin C et al. N Engl J Med 2020;382:1124-35.
4. Public Health Agency of Canada . Summary: Estimates of HIV Incidence, Prevalence and Canada's Progress on Meeting the 90-90-90 HIV targets, 2016. Public Health Agency of Canada , 2018. Available at: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/summary-estimates-hiv-incidence-prevalence-canadas-progress-90-90-90/pub-eng.pdf . Accessed September 16, 2020 .
SOURCE ViiV Healthcare
