-- 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 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 CAn 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 MAVIRETMAVIRET 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 CareCanadians 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 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. 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.
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Media: Muriel Haraoui, AbbVie Canada, 514-717-3764, email@example.com