AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) Approved by European Commission to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis

- MAVIRET™ is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5 and 6

- Marketing authorization is supported by 97.9 percent cure* rate across this group of patients with no reported virologic failures¹

- Analysis evaluating MAVIRET as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is ongoing

NORTH CHICAGO, Illinois, Aug. 2, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET™ (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5, and 6 infection. An analysis from the same clinical trial evaluating MAVIRET as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is ongoing. MAVIRET is also currently approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve patients without cirrhosis.²**

"MAVIRET has already had a significant impact on the lives of hundreds of thousands of people affected by chronic HCV, and with this approval, we are one step closer to providing more HCV patients with an option to treat their chronic disease with a once-daily, 8-week regimen," said Janet Hammond M.D., vice president, general medicine and virology therapeutic area, AbbVie.

The marketing authorization is supported by data from the ongoing Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET, 97.9 percent (n=274/280) of GT1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR₁₂) (ITT).¹ To date, no virologic failures have been reported in these patients and no patients have discontinued treatment due to adverse events.¹ Adverse events (frequency >5%) reported in the study include pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%).¹ Six serious adverse events (2%) have occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir.¹ No new safety signals were identified in this study.¹ These data were presented as a late-breaking, oral presentation at The Liver Meeting® 2018 organized by the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California.

The ongoing Phase 3b EXPEDITION-8 study is evaluating the safety and efficacy of MAVIRET in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6).¹ The results have been reported for GT1, 2, 4, 5, and 6 (n=280) patients. Enrollment and treatment of the GT3 patient population was completed later, therefore the analysis of this population is ongoing.

"There are still a significant number of HCV patients with varied patient and viral characteristics who are in need of options," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "We are working hard to help support achieving the World Health Organization's goal of eliminating HCV by 2030 and having additional patient populations eligible for shorter-term, 8-week treatment options could help bring us closer to that goal."

About the EXPEDITION-8 Study¹
EXPEDITION-8 is an ongoing non-randomized, single arm, open-label, multicenter Phase 3b study evaluating the safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve GT1-6 chronic HCV patients with compensated cirrhosis. Analysis of the GT3 patient population is ongoing.

The primary efficacy endpoints are the SVR₁₂ rates in patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and intent-to-treat (ITT) population versus respective historical SVR₁₂ rates based on the efficacy of MAVIRET for 12 weeks in treatment-naïve patients with compensated cirrhosis. The SVR₁₂ rates were 97.9 percent (n=274/280) and 100 percent (n=273/273) in the ITT and PP populations, respectively. From the 280 patients with GT1, 2, 4, 5 or 6 enrolled, seven were excluded from the SVR₁₂ per-protocol analysis (n=273); five patients were lost to follow up, and two patients received less than 8 weeks of treatment (one of these two patients achieved SVR₁₂). The key secondary efficacy endpoints are the percentages of GT1, 2, 3, 4, 5, and 6 patients achieving SVR₁₂ in a PP and ITT population.

About MAVIRET™ (glecaprevir/pibrentasvir)
MAVIRET® is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents 12 to <18 years old across all major genotypes (GT1-6). MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

Maviret is an 8-week, pan-genotypic option (GT1-6) for patients who are new to treatment and without cirrhosis and for GT1, 2, 4, 5 and 6 patients who are new to treatment with compensated cirrhosis. The recommended duration of therapy for treatment-naive, compensated cirrhotic GT3 HCV patients is 12 weeks. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD. MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B).²

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

EU Indication
MAVIRET is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents 12 to <18 years old.

Important EU Safety Information

Contraindications:
MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers, such as rifampicin, carbamazepine, St. John's wort, phenobarbital, phenytoin, and primidone.

Special warnings and precautions for use:
Hepatitis B virus reactivation
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment.

Hepatic impairment
MAVIRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B).

Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor
MAVIRET is not recommended for the re-treatment of patients with prior exposure to NS3A/4A and/or NS5A-inhibitors.

Use in diabetic patients
Diabetics may experience improved glucose control and potential symptomatic hypoglycaemia after initiating HCV direct acting antiviral treatment. Glucose levels should be closely monitored, particularly within the first 3 months of treatment.

Adverse Reactions
Most common (≥10%) adverse reactions for MAVIRET were headache and fatigue.

This is not a complete summary of all safety information. See MAVIRET full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

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.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Related Links

abbvie.com