- MAVIRET is now listed under the "Régie de l'assurance
maladie du Québec" List of Medications.
- 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, April 11, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global, research and development-based biopharmaceutical company
announced today that MAVIRETTM (glecaprevir/pibrentasvir
tablets) is now listed as a medication covered under Quebec's public drug insurance plan. 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.*
"Every day at my clinic I see the devastating effects of
hepatitis C. The complications from this disease can be fatal,"
stresses Dr. Marc Poliquin, a gastroenterologist with the
Clinique de médecine urbaine du Quartier latin and at Hôpital
Verdun – CIUSSS du
Centre‑Sud‑de‑l'Île-de-Montréal. "Canada is looking to eliminate HCV and
MAVIRET, a combination of glecaprevir and pibrentasvir, will help
in achieving this objective. When I talk about MAVIRET to my
patients, I can give them hope—even the most vulnerable patients.
The treatment is short and effective, and has very few related side
effects. We may possibly be able to eradicate this disease in
Canada and, above all, avoid or
reduce complications such as cirrhosis, liver cancer and the need
for liver transplantation."
The reimbursement criteria for MAVIRET are as
follows:3
- As monotherapy for treatment of persons suffering from chronic
hepatitis C who have never received an anti-HCV treatment.
- As monotherapy for treatment of persons suffering from chronic
hepatitis C genotype 1, 2, 4, 5 or 6 who have experienced
therapeutic failure with a treatment based on pegylated interferon
(peg IFN) alfa- or based on sofosbuvir, but who have never been
treated with either an NS3/4A protease inhibitor nor with an NS5A
protein inhibitor.
- As monotherapy for treatment of persons suffering from chronic
hepatitis C genotype 3 without decompensated cirrhosis and who have
experienced treatment failure with an association of
ribavirin/pegylated interferon alfa or with an association of
sofosbuvir/ribavirin, but have never been treated with either an
NS3/4A protease inhibitor or NS5A protein inhibitor.
- As monotherapy for treatment of persons suffering from chronic
hepatitis C genotype 1 without decompensated cirrhosis and who have
experienced therapeutic failure with an NS3/4A protease inhibitor,
but who have never been treated with an NS5A protein
inhibitor.
- As monotherapy for treatment of persons suffering from chronic
hepatitis C genotype 1 without decompensated cirrhosis and who have
experienced therapeutic failure with an NS5A protein inhibitor, but
who have never been treated with an NS3/4A protease inhibitor.
"For 15 years, the Centre Associatif Polyvalent d'Aide
Hépatite C (CAPAHC), a hepatitis C support group, has been
providing assistance to people living with HCV, while making
Quebeckers aware of this insidious disease," explains
Laurence Mersilian, the centre's general manager. "Today,
thanks to treatments like MAVIRET, we can confidently tell our
members and their loved ones that we are on the path towards
eliminating this virus. However, we need to continue to work
together on information, education and screening programs to meet
World Health Organization targets."
Approximately 300,000 Canadians are infected with chronic
HCV.4 In Quebec, the
number of reported cases is 39,136; however, the total number of
people living with the disease is estimated to be 70,000. The
prevalence is 0.74%. HCV is also the leading cause of liver
transplantation in Canada, with an
HCV–related death curve exceeding that of the human
immunodeficiency virus (HIV) worldwide.5
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 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
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 April 2019.
|
3
|
Régie de l'assurance
maladie du Québec. List of medications. Last updated April 11,
2019.
www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/2019/liste_med_2019_04_11_en.pdf.
Accessed April 2019.
|
4
|
The Canadian Liver
Foundation. www.liver.ca/how-you-help/advocate/. Accessed March
2019.
|
5
|
Centre Associatif
Polyvalent d'Aide Hépatite C. Hepatitis C: Frequently Asked
Questions. www.capahc.com/hepatitis-c-faq/. Accessed April
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 April 2019.
|
SOURCE AbbVie