- MAVIRET® is an 8-week, pan-genotypic treatment for adults
and adolescent patients 12 to 18 years of age with chronic
hepatitis C virus (HCV) infection without cirrhosis and who are new
to treatment.*1
- MAVIRET is approved for use in patients across all stages of
chronic kidney disease (CKD).
- MAVIRET is now available and reimbursed across Canada.
MONTREAL, Jan. 14, 2020 /CNW/ - AbbVie (NYSE: ABBV), a
global, research and development-based biopharmaceutical company
announced today that MAVIRET® (glecaprevir/pibrentasvir tablets) is
now listed on the Newfoundland and
Labrador Formulary. MAVIRET is a once-daily ribavirin-free
treatment for adults and adolescent patients 12 to 18 years of age
with chronic hepatitis C virus (HCV) infection across all major HCV
genotypes (GT1-6).2 It is an 8-week, pan-genotypic
treatment for patients without cirrhosis and who are new to
treatment.*
"As a nurse practitioner, I see firsthand the devastating
effects hepatitis C has in our communities and on those living with
this disease. But we can change the narrative because we have all
the right tools to eliminate this disease. We have the
understanding, knowledge, resources and treatments like MAVIRET, to
educate and treat everyone living with hepatitis C," says
Kimberley A. Burt RN, BN, NP,
Provincial Immunodeficiency Nurse Practitioner, Eastern Health,
St. John's, Newfoundland.
MAVIRET is listed on the Newfoundland and Labrador
Formulary for treatment-naive or treatment-experienced
adult patients with chronic hepatitis C genotype 1,2,3,4,5 or 6
infection.3
"Our vision is to work together to create a province without
hepatitis C. To achieve this goal, we have to continue to raise
awareness, educate, support people living with and/or affected by
hepatitis C, as well as advocate for change," explains Gerard Yetman, Executive Director, AIDS
Committee of Newfoundland and
Labrador. "We strongly believe
that the newer treatments, such as MAVIRET, will have a positive
impact and help us fulfill our mandate to eliminate hepatitis C
from our province."
MAVIRET's efficacy and safety were evaluated in nine phase
II-III clinical trials, in over 2300 patients with genotype 1, 2,
3, 4, 5 or 6 HCV infection and with compensated liver disease (with
or without cirrhosis).
About Hepatitis C
An estimated 250,000 people in
Canada are living with chronic
hepatitis C but as many as 44% are not aware that they have
it.4 Left undiagnosed and untreated, chronic hepatitis C
can lead to cirrhosis, liver cancer or liver failure. Currently,
hepatitis C is the leading indication for liver transplant in
Canada.5 AbbVie
supports a range of efforts to help elevate and prioritize HCV
elimination because we know achieving the shared goal of
elimination by 2030 will take more than medicine. It will take
transparent and collaborative partnerships with all stakeholders –
industry, healthcare providers, healthcare systems, patient groups
and their support networks. Joint efforts and maximizing the time
we have left will enable us to reach this goal.
About MAVIRET
MAVIRET is approved in Canada for the treatment of chronic hepatitis
C virus (HCV) in adults and adolescent patients 12 to 18 years of
age across all major genotypes (GT1-6).6 MAVIRET is
a pan-genotypic, once-daily, ribavirin-free treatment that combines
glecaprevir (100 mg), an NS3/4A protease inhibitor, and
pibrentasvir (40 mg), an NS5A protein inhibitor. MAVIRET is
taken once daily as three oral tablets.6
MAVIRET is an 8-week, pan-genotypic treatment that makes a
virologic cure** possible in patients without cirrhosis who are new
to treatment.*1 These patients represent the majority of
people infected with HCV. MAVIRET is also approved in patients with
specific treatment challenges, including those with compensated
cirrhosis, who are carriers of one of the major genotypes, and
those who previously had limited treatment options, such as
patients with severe CKD, post-liver and post-renal transplant
recipients*** and those patients with genotype 3 HCV
infection.6 MAVIRET is approved for use in patients
across all stages of CKD.6
Glecaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) to
develop HCV protease inhibitors and therapeutic regimens that
include protease inhibitors.
* Patients without
cirrhosis and new to treatment with direct-acting antivirals
(DDAs), (i.e., either treatment-naive or did not respond to
previous interferon-based treatments (pegylated interferon [peg
IFN] +/- ribavirin or sofosbuvir-ribavirin +/-peg
IFN). ** Patients who achieve a sustained virologic
response at 12 weeks post treatment (SVR12) are
considered cured of hepatitis C. ***MAVIRET
is recommended for 12 weeks in liver or kidney transplant
recipients who are HCV GT1-6 treatment-naive or HCV GT-1, -2, -4,
-5 or -6 PRS (IFN or peg IFN, ribavirin and/or
sofosbuvir)-treatment experienced. A 16-week treatment duration
should be considered in transplant patients who are HCV GT-1 NS5A
inhibitor experienced (but NS3/4A inhibitor-naive) or HCV GT-3 PRS-
treatment experienced.
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About AbbVie Care
Canadians prescribed MAVIRET can be
enrolled in AbbVie Care, AbbVie's signature care program. The
program is designed to provide a wide range of customized services
including reimbursement and financial support, pharmacy services,
personalized education and ongoing disease management support
throughout the treatment.
About AbbVie
AbbVie is a global, research and
development-based 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.
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2 CADTH
Canadian Drug Expert Committee Recommendation – Final.
www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf.
Accessed January 2020.
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3
Newfoundland and Labrador. Department of Health and Community
Services. https://nlpdp.bell.ca/default.aspx. Accessed June
2019.
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4 Canadian
Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C
elimination efforts in Canada.
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www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf.
Accessed January 2020.
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5 The
Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/.
Accessed January 2020.
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6 AbbVie
Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product
Monograph. Date of Preparation: August 16, 2017. Date of Revision:
June 25, 2019.
www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf.
Accessed January 2020.
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SOURCE AbbVie Canada