European Commission Grants AbbVie Marketing Authorization Shortening MAVIRET® (glecaprevir/pibrentasvir) Treatment Duration to Eight Weeks for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis

NORTH CHICAGO, Ill., March 6, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission has approved a change to the 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) 3 infection. MAVIRET was already indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.^1*

"A shorter treatment duration means that more patients with HCV can be treated with an 8-week course of MAVIRET in the absence of initial tests to determine their genotype or degree of fibrosis or cirrhosis," said Janet Hammond M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie. "The ability to streamline pre-treatment assessment for people with HCV represents a paradigm shift in the way the disease is treated, potentially accelerating the care cascade and allowing us to make greater strides towards achieving the World Health Organization's goal of eliminating HCV by 2030."

The EC approval is supported by data from the Phase 3b EXPEDITION-8 study. The Phase 3b EXPEDITION-8 study evaluated the safety and efficacy of MAVIRET in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The results have been reported for GT1, 2, 3, 4, 5, and 6 (n=343) patients² and showed that with 8 weeks of MAVIRET, 97.7 percent (n=335/343) of GT1- 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR₁₂) (ITT). For patients with GT3, the SVR₁₂ rate was 95.2% (n= 60/63) (ITT).**

To date, one virologic failure has been reported and no patients have discontinued treatment due to adverse events. In the study, most patients that did not achieve SVR₁₂** were lost to follow up versus experiencing treatment failure, and no new safety signals were identified.²

"Despite hepatitis C now being curable, there are millions of people in Europe who are chronically infected with the virus. Many of these patients have never received treatment, often because they have been unable to navigate the practical and clinical complexities of the treatment journey," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "A shorter-duration therapeutic option and simplified pre-treatment approach can eliminate the need for extra tests and help significantly more people overcome their very real treatment barriers." 

In the World Health Organization (WHO) European Region, 14 million people are estimated to be chronically infected with the hepatitis C virus and many of them are unaware that they are infected.³ Each year 112,500 people die from hepatitis C-related liver disease.³

About the EXPEDITION-8 Study²
EXPEDITION-8 is a single-arm, open-label, Phase 3b study in treatment-naïve, GT1-6 chronic HCV patients with compensated cirrhosis (n=343) who received MAVIRET for 8 weeks.

The primary efficacy endpoints were SVR₁₂** in patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and intent-to-treat (ITT) population versus historical SVR₁₂** rates based on the efficacy of MAVIRET for 12 weeks in treatment-naïve patients with compensated cirrhosis. The key secondary efficacy endpoints were the percentages of GT1-6 patients achieving SVR₁₂** in a PP and ITT population.

Additional information on the clinical trials for MAVIRET is available at www.clinicaltrials.gov/.

About MAVIRET^® (glecaprevir/pibrentasvir)¹
MAVIRET is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to <18 years 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 (GT 1-6) option for patients without cirrhosis or with compensated cirrhosis and who are new to treatment.* 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).

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals 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 aged 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.

* The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients without cirrhosis or with compensated cirrhosis.
** Sustained virologic response (SVR12), defined as HCV RNA less than lower limit of quantification (LLOQ) at 12 weeks after the end of treatment, was the primary endpoint in all the studies.

¹ MAVIRET^® tablets (glecaprevir/pibrentasvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.
² Brown RS et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019) the HCV cure rate. (ref 1)
³ Hepatitis C in the WHO European Region. WHO Fact Sheet July 2019. Available at: http://www.euro.who.int/__data/assets/pdf_file/0009/377253/Fact-Sheet-Hepatitis-C_2019_ENG.PDF?ua=1  Last accessed February 2020

SOURCE AbbVie

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