-- 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).
AbbVie (NYSE:ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRET(TM) (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 MAVIRETMAVIRET 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 (SVR(12)) 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.
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Media: Muriel Haraoui, AbbVie Canada, 514-717-3764, firstname.lastname@example.org