- 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, June 10, 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 Nova Scotia Formulary and on the
Manitoba Drug Benefits and Interchangeability Formulary, both
effective since May 31, 2019. 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.*
"In Nova Scotia, it is possible
to reach the World Health Organization's target of eliminating
viral hepatitis as a major public threat by 2030. But in order to
be successful, we need to implement strategies that include
prevention, screening, timely and rapid testing, effective
treatment and patient centred care for everyone living with
hepatitis C," says Dr. Lisa Barrett,
MD, PhD, FRCPC, Assistant professor, Division of Infectious
Diseases, Department of Medicine, Department of
Microbiology & Immunology, Dalhousie University. "Today,
with treatments including MAVIRET, we should be able to treat
almost all people living with hepatitis C infection regardless
of their background. This is very important for each individual
person but also for elimination because treatment helps prevent the
spread of HCV."
MAVIRET is listed on the Nova Scotia Formulary
for treatment-naive or treatment-experienced adult patients
with chronic hepatitis C genotype 1,2,3,4,5 or 6
infection.3
"At the Hepatitis Outreach Society of Nova Scotia (HepNS), we've worked over the
last decade to promote healthy living through information and
support for people living with hepatitis C. But more importantly,
we've been committed to reducing the transmission rates. We are
hopeful that with newer medications like MAVIRET being available in
Nova Scotia and New Brunswick, our members will be able to
seek the appropriate treatment and finally shed the stigma
associated with this disease," explains Alex MacDonnell, Acting Executive Director of
HepNS.
MAVIRET is listed on the Manitoba Drug Benefits and
Interchangeability Formulary for treatment-naive or
treatment-experienced adult patients with chronic hepatitis C
genotype 1,2,3,4,5 or 6 infection.4
"Hepatitis C is a serious health concern. When left untreated it
leads to complications including liver cancer," explains Dr.
Kelly Kaita, Hepatologist, Director,
Viral Hepatitis Investigative Unit at the University of Manitoba. "Today, we have the
knowledge and the expertise to test, diagnose and treat Canadians
living with this deadly disease. Moreover, we have the right
treatments, such as MAVIRET, that can cure the disease in as little
as eight weeks. Now is the time to act, especially as we are
working towards eradicating this virus by 2030."
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.5 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.6 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).7 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.7
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.7 MAVIRET is the only pan-genotypic
treatment approved for use in patients across all stages of
CKD.7
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.
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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 June 2019.
|
3 Nova
Scotia Pharmacare. Nova Scotia Formulary.
https://novascotia.ca/dhw/pharmacare/pharmacists_bulletins/Pharmacists_Bulletin_May_19-04.pdf.
Accessed June 2019.
|
4 Manitoba Pharmacare Program.
Manitoba Drug Benefits and Interchangeability Formulary.
www.gov.mb.ca/health/mdbif/bulletin104.pdf. Accessed June
2019.
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5 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 June 2019.
|
6 The
Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/.
Accessed June 2019.
|
7 AbbVie Corporation MAVIRET
(glecaprevir/pibrentasvir tablets) Product Monograph. Date of
Preparation: August 16, 2017. Date of Revision: November
28, 2018.
http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf.
Accessed June 2019.
|
SOURCE AbbVie