- MAVIRET is the first and only 8-week, pan-genotypic
treatment for patients with chronic hepatitis C virus (HCV)
infection without cirrhosis and who are new to
treatment.*1
- MAVIRET is the only pan-genotypic treatment approved for use
in patients across all stages of chronic kidney disease
(CKD).
MONTREAL, May 30, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global, research and development-based biopharmaceutical company
announced today that MAVIRETTM (glecaprevir/pibrentasvir
tablets) is now listed on the New Brunswick Drug Plans Formulary.
MAVIRET is a once-daily ribavirin-free treatment for adults with
chronic hepatitis C virus (HCV) infection across all major HCV
genotypes (GT1-6).2 It is the only 8-week, pan-genotypic
treatment for patients without cirrhosis and who are new to
treatment.*
"Hepatitis C is the leading cause of liver failure and liver
cancer in New Brunswick," states
Dr. Meaghan O'Brien, Hepatologist,
Upper River Valley Hospital, Assistant professor, Division of
General Internal Medicine, Department of Medicine,
Dalhousie University. "With the
introduction and subsequent approval and reimbursement of the new
direct-acting antiviral therapies, such as MAVIRET, we have an
opportunity to treat all Canadians living with this devastating and
deadly disease. However, we need to ensure that the proper models
of care are in place in order to reach our objectives both locally
and across Canada."
On the New Brunswick Drug Plans Formulary, MAVIRET is listed for
treatment-naïve or treatment-experienced adult patients with
chronic hepatitis C virus (HCV) including all genotypes 1-6. The
listing became effective on May 16,
2019.3
"AbbVie believes that together, through innovative partnerships,
we can make hepatitis C elimination the next public health success
story. Along with healthcare professionals, governments and patient
associations, together we can meet the WHO 2030 objective," says
Stéphane Lassignardie, General Manager, AbbVie Canada. "We are
committed to further investigating and identifying opportunities to
simplify the path to a cure."
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 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 the only pan-genotypic
treatment 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.
About AbbVie Care
Canadians prescribed MAVIRET will
have the opportunity to 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.
|
2
|
CADTH Canadian Drug
Expert Committee Recommendation – Final:
www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf.
Accessed May 2019.
|
3
|
New Brunswick
Prescription Drug Program.
www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/FormularyUpdates/NBDrugPlansBulletin999.pdf.
Accessed May 2019.
|
4
|
Canadian Network on
Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination
efforts in Canada.
www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf.
Accessed May 2019.
|
5
|
The Canadian Liver
Foundation. www.liver.ca/how-you-help/advocate/. Accessed May
2019.
|
6
|
AbbVie Corporation
MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date
of Preparation: August 16, 2017. Date of Revision: November
28, 2018.
www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.p .
Accessed May 2019.
|
SOURCE AbbVie