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 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