AbbVie’s MAVIRET (Glecaprevir/Pibrentasvir) Receives EU Approval as the Only Pan-Genotypic 8-Week Regimen for Hepatitis C, Now Available in China
Mar 09, 2020 15:42
CST Updated
Mar 07, 10:38
AbbVie
Innovative Drug Developer
March 07, 2020 /BioValleyBIOON/ -- AbbVie recently announced that the European Commission (EC) has approved a variation to the marketing authorization for the pan-genotypic hepatitis C therapy Maviret (Chinese brand name: Ainuoquan; generic name: glecaprevir/pibrentasvir), shortening the treatment duration from 12 weeks to 8 weeks for treatment-naive patients with genotype 3 (GT 3) chronic hepatitis C (HCV) and compensated cirrhosis.
Previously, the indications for Maviret in the European Union were: (1) as an 8-week, pangenotypic (GT 1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis; (2) as an 8-week, once-daily regimen for treatment-naïve HCV patients with compensated cirrhosis infected with genotypes 1, 2, 4, 5, or 6; (3) for treatment-naïve patients with compensated cirrhosis infected with genotype 3, the recommended treatment duration for Maviret was 12 weeks.
This approval enablesMaviret Becomes the Only Pangenotypic (GT 1-6) 8-Week Regimen Approved in the EU for the Treatment of HCV Patients, Whether Treatment-Naïve with or Without Compensated Cirrhosis, Regardless of Genotype
Janet Hammond, M.D., Vice President of the Integrated Medical and Virology Therapeutic Area at AbbVie, stated, “Shorter treatment duration means that more patients with hepatitis C can receive an eight-week course of Maviret without undergoing preliminary tests to determine their genotype or the extent of fibrosis or cirrhosis. The ability to simplify pre-treatment assessment for hepatitis C patients represents a paradigm shift in treatment approaches, potentially accelerating the care cascade and enabling us to make greater strides toward achieving the World Health Organization’s (WHO) 2030 goal of eliminating hepatitis C.”
This approval is based on data from the Phase IIIb EXPEDITION-8 study. The study evaluated the efficacy and safety of Maviret in treatment-naïve patients with compensated cirrhosis and hepatitis C virus (HCV) genotypes 1–6 (n=343). Data showed that the 8-week Maviret regimen achieved a virologic cure rate (SVR12, defined as sustained virologic response 12 weeks after completion of therapy) of 97.7% (n=335/343) in patients with genotypes 1–6 and 95.2% (n=60/63) in patients with genotype 3. To date, one case of virologic failure has been reported in these patients, and no patients discontinued treatment due to adverse events. Adverse events reported in the study (incidence >5%) included pruritus (8%), fatigue (9%), headache (8%), and nausea (6%). Six serious adverse events (2%) occurred during the study, none of which were considered related to Maviret. No new safety signals were identified in this study.
Stefan Zeuzem, MD, Director of the Department of Medicine at Goethe University Hospital in Frankfurt, Germany, stated: “Although hepatitis C is now curable, millions of people in Europe remain chronically infected with the hepatitis C virus. Many patients have never received treatment, often because they are unable to navigate the practical and clinical complexities involved in the treatment process. Shortening the duration of therapy and simplifying pre-treatment approaches can eliminate the need for additional tests, helping more patients overcome the true barriers to treatment.”
In the World Health Organization (WHO) European Region, an estimated 14 million people are chronically infected with the hepatitis C virus, many of whom are unaware of their infection. Each year, 112,500 people die from hepatitis C-related liver disease.。
Maviret is a pan-genotypic, once-daily, ribavirin-free therapeutic regimen composed of two fixed-dose antiviral agents: glecaprevir (G, 100 mg), an NS3/4A protease inhibitor, and pibrentasvir (P, 40 mg), an NS5A inhibitor. Maviret is administered once daily as three tablets.
Maviret is approved for the treatment of hepatitis C virus (HCV) infection across all major genotypes (GT1–6) in adolescents (aged 12 to 18 years) and adults. Maviret is an 8-week pangenotypic (GT1–6) regimen indicated for treatment-naïve patients without cirrhosis, as well as for treatment-naïve patients with compensated cirrhosis.
Maviret is also approved for the treatment of patients with special challenges, including those with all major genotypes and compensated cirrhosis, as well as patients with previously limited treatment options, such as those with severe chronic kidney disease (CKD) or genotype 3 (GT3). Maviret is approved for use in patients with CKD at all stages. The drug is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended for patients with moderate hepatic impairment (Child-Pugh B).
In China, Maviret (glecaprevir/pibrentasvir) was approved in May 2019 for the treatment of adult patients with hepatitis C virus (HCV) infection of all major genotypes (GT 1, 2, 3, 4, 5, and 6), who have either no cirrhosis or compensated cirrhosis. With an 8-week cure rate for hepatitis C, Maviret was included in the second batch of urgently needed overseas new drugs published by the National Medical Products Administration (NMPA) due to its "therapeutic advantages over marketed products."
MaviretClinical TrialData show that for treatment-naïve, non-cirrhotic patients with all major hepatitis C genotypes (GT1–6), the virologic cure rate exceeds 99%, with a treatment duration as short as 8 weeks. This regimen does not require ribavirin co-administration and involves once-daily oral dosing. As Maviret is not metabolized by the kidneys, it is suitable for patients with any degree of renal impairment (including those undergoing dialysis) without dose adjustment, achieving a virologic cure rate of nearly 100% and demonstrating a favorable safety profile. (Bioon.com)