ABBV AbbVie Inc

• 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 MAVIRET^TM (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.

SOURCE AbbVie