European Commission Grants AbbVie Marketing Authorization for Shorter MAVIRET Treatment

AbbVie 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.

"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.

"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. Each year 112,500 people die from hepatitis C-related liver disease.

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.

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.

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