- MAVIRET is the first and only 8-week, pan-genotypic
treatment for hepatitis C patients without cirrhosis and who are
new to treatment*1
- The approval is supported by a 97 percent (n=639/657)
cure** rate across GT1-6 patients without cirrhosis and
who are new to treatment2
- MAVIRET is the only pan-genotypic treatment approved for use
in patients across all stages of chronic kidney disease
MONTREAL, Aug. 17, 2017 /CNW/ - AbbVie (NYSE: ABBV), a
global biopharmaceutical company, today announced that Health
Canada has granted approval for MAVIRET™ (glecaprevir/pibrentasvir
tablets), a once-daily, ribavirin-free treatment for adults with
chronic hepatitis C virus (HCV) infection across all major
genotypes (GT1-6). MAVIRET is the only 8-week, pan-genotypic
treatment for patients without cirrhosis and who are new to
treatment,* who make up a large portion of HCV patients
in Canada.
"Despite recent advances in HCV treatment, physicians still face
challenges treating patients with less common genotypes and those
with other complicating health conditions," said Dr. Morris Sherman, MD, FRCPC, Chairperson, Canadian
Liver Foundation. "In order to eliminate hepatitis C in
Canada, we need to identify all
those living with the virus and have effective treatment options
for everyone. This new therapy provides another tool for physicians
to expand treatment to a greater number of patients while at the
same time shortening the duration which may lead to cost savings
for the health care system."
MAVIRET is also approved for use in patients with specific
treatment challenges, including those with compensated cirrhosis
across all major genotypes, and those who previously had limited
treatment options, such as patients with severe chronic kidney
disease (CKD), those GT1 patients not previously cured with certain
direct-acting antiviral (DAA) treatment, and those with GT3 chronic
HCV infection.2 MAVIRET is the only pan-genotypic
treatment approved for use in patients across all stages of
CKD.2
"With the approval of MAVIRET, we are proud to bring the hope of
a new cure to people living with hepatitis C in Canada, reflecting AbbVie's dedication to
addressing critical unmet needs for patients," said Stéphane
Lassignardie, General Manager, AbbVie Canada. "MAVIRET is designed
to deliver a virologic cure for most HCV patients including those
with specific treatment challenges. AbbVie will continue to work
with local health authorities and stakeholders across Canada to get our treatment to as many
patients as possible."
The efficacy and safety of MAVIRET was evaluated in nine Phase
2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3,
4, 5 or 6 HCV infection and with compensated liver disease (with or
without cirrhosis).
Approximately 300,000 Canadians are infected with hepatitis
C.3 In 2012 alone, more than 10,000 new cases of
hepatitis C were reported, but 40 percent of patients are estimated
to be living unaware of their disease.4 GT1 is the most
common genotype in Canada and GT3
is the most difficult to treat.3,5 Over time chronic
hepatitis C can lead to chronic liver diseases, with a risk of
developing cirrhosis of up to 30 percent within 20
years6 of infection. Additionally, HCV is common among
people with severe CKD, and some of these patients previously did
not have a DAA-based treatment option.7
With 8 weeks of treatment, 97 percent (n= 639/657) of GT1-6
patients without cirrhosis and who were new to treatment achieved a
virologic cure.1 These high cure rates were achieved in
patients with varied patient and viral characteristics and
including those with CKD.2 Additionally, 97.5 percent
(n=274/281) of patients with compensated cirrhosis achieved a
virologic cure with the recommended duration of treatment,
including patients with CKD.2 In registrational studies
for MAVIRET, less than 0.1 percent of patients permanently
discontinued treatment due to adverse reactions.2 The
most commonly reported adverse reactions (incidence greater than or
equal to 10 percent) were headache and fatigue.2
"In an extensive clinical trial program, patients achieved high
cure rates with MAVIRET regardless of genotype, fibrosis score,
viral load, and even in patients with resistant virus strains and
those with chronic kidney disease," said Dr. Magdy Elkhashab,
Gastroenterologist/Hepatologist, Director of the Toronto Liver
Centre. "In clinical practice, MAVIRET has the potential to
simplify treatment decisions for physicians, offering, in one
therapy, a cure for the majority of HCV patients and cutting out
pre-testing before treatment initiation."
MAVIRET combines two new, potent direct-acting antivirals that
target and inhibit proteins essential for the replication of
the hepatitis C virus.2 The presence of most
genotypes or baseline mutations that are commonly associated with
resistance have been shown to have no relevant impact on
efficacy.2
Canadians prescribed MAVIRET will have the opportunity to be
enrolled in AbbVie Care, AbbVie's signature patient support program
designed to provide a wide range of services including
reimbursement assistance, education and ongoing disease management
support. AbbVie Care will support people living with HCV throughout
their treatment journey to achieve high cure rates in the real
world.
Approval of MAVIRET followed Health Canada's Priority Review
process, which is granted to new medicines intended for patients
with a life-threatening disease where there is no existing
treatment with the same profile or where the new product represents
a significant improvement in the benefit/risk profile over existing
products.8 AbbVie's investigational, pan-genotypic
regimen was also recently approved by the European Commission and
the U.S. Food and Drug Administration.
About MAVIRET™
MAVIRET™ is approved in Canada for the treatment of chronic hepatitis
C virus (HCV) infection in adults across all major genotypes
(GT1-6).2 MAVIRET is a new, pan-genotypic, once-daily,
ribavirin-free treatment that combines glecaprevir (100 mg), an
NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A
inhibitor, dosed once-daily as three oral tablets.2
MAVIRET is an 8-week, pan-genotypic virologic cure**
for use in patients without cirrhosis and who are new to
treatment,* such patients comprising the majority
of people living with HCV.1 MAVIRET is also approved as
a treatment for patients with specific treatment challenges,
including those with compensated cirrhosis across all major
genotypes, and those who previously had limited treatment options,
such as patients with severe chronic kidney disease (CKD) and those
with genotype 3 infection.2 It is the only pan-genotypic
treatment approved for use in patients across all stages of
CKD.2
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
*Patients without cirrhosis and new to treatment with DAAs
[either treatment-naive or not cured with previous IFN-based
treatments ([peg]IFN +/- RBV or SOF/RBV +/-
pegIFN)].
**Patients who achieve a sustained virologic
response at 12 weeks post treatment (SVR12) are
considered cured of hepatitis C.
About AbbVie
AbbVie is a global, research-driven
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.ca and
www.abbvie.com. Follow @abbvieCanada and @abbvie on
Twitter or view careers on
our Facebook or LinkedIn page.
1 Decisions Resources Group. Hepatitis C virus:
disease landscape & forecast 2016. January 2017.
2 MAVIRET (glecaprevir/pibrentasvir tablets) Product
Monograph. Date of Preparation: August 16,
2017.
3 Messina, JP et al.
"The global distribution of HCV genotypes." Hepatology, 2015; 61:
77–87. Supporting information hep27259-sup-0001-suppinfo.pdf.
Accessed August, 2017.
4 Hepatitis C: Get the Facts. Government of Canada.
https://www.canada.ca/en/public-health/services/publications/diseases-conditions/poster-hepatitis-c-get-facts.html.
Accessed August, 2017.
5 Wyles, D et al. SURVEYOR-II, Part 3: Efficacy and
Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus
Genotype 3 Infection with Prior Treatment Experience and/or
Cirrhosis. Presented at the Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) in Boston, US on November
11-15, 2016.
6 Hepatitis C Fact Sheet. World Health Organization.
World Health Organization, July 2017.
Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed
August, 2017.
7 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection
in the patient with end stage renal disease. Hepatology.
2002;36(1):3-10.
8 Priority Review of Drug Submissions. Government of
Canada.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/priority-review-drug-submissions-therapeutic-products.html.
Accessed August, 2017.
SOURCE AbbVie Canada