AbbVie’s Pan-Genotypic HCV Therapy Maviret (Glecaprevir/Pibrentasvir) Receives EU Approval for 8-Week Regimen and Launches in China with >99% Cure Rate
Aug 03, 2019 14:03
CST Updated
14:03
AbbVie
Innovative Drug Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
August 03, 2019 News /BioValleyBIOON/ -- U.S. biotechnology giant AbbVie's pangenotypic hepatitis C cocktail therapy Maviret (Chinese trade name:Maviret (generic name: glecaprevir/pibrentasvir)Recent Good News in EU Regulatory Affairs. The European Commission (EC) has approved the short-course regimen of Maviret (once daily for 8 weeks) for the treatment of previously untreated (treatment-naïve) patients with chronic hepatitis C virus (HCV) infection of genotypes (GT) 1, 2, 4, 5, or 6, compensated cirrhosis. A study from the sameClinical Trialsanalysis is evaluating the 8-week Maviret regimen for treatment-naïve patients with compensated cirrhosis infected with genotype 3 (GT3) hepatitis C virus (HCV). Currently, Maviret is also approved as an 8-week pangenotypic (GT1-6) therapy for treatment-naïve patients without cirrhosis.
This approval is based on data from the ongoing Phase IIIB clinical study EXPEDITION-8. The study demonstrated that the virologic cure rate (SVR12) was 97.9% among patients with genotypes 1, 2, 4, 5, and 6 following an 8-week course of Maviret treatment. To date, no virologic failures have been reported in these patients, and no patients discontinued treatment due to adverse events. Adverse events reported in the study (with an incidence >5%) included pruritus (9.6%), fatigue (8.6%), headache (8.2%), and nausea (6.4%). Six serious adverse events (2%) occurred during the study, all of which were considered unrelated to glecaprevir/pibrentasvir. No new safety signals were identified in this study. These data were presented at the 2018 Liver Meeting organized by the American Association for the Study of Liver Diseases (AASLD).Conferencepresented at The Liver Meeting® 2018.
The ongoing Phase IIIB EXPEDITION-8 study is evaluating Maviret for the treatment of treatment-naïve patients with chronic HCV and compensated cirrhosis across all major genotypes (GT1–6). Data have already been reported for patients with GT1, 2, 4, 5, and 6 (n=280). Enrollment and treatment completion for patients with GT3 occurred later, and analysis in this patient population is currently underway.
Stefan Zeuzem, MD, Director of the Department of Medicine at Goethe University Hospital in Frankfurt, Germany, stated, “There is still a substantial number of patients with HCV, exhibiting diverse patient and viral characteristics, who require treatment options. We are striving to help achieve the World Health Organization’s (WHO) goal of eliminating hepatitis C virus (HCV) by 2030. Expanding eligibility for short-term, 8-week treatment regimens to broader patient populations will bring us closer to this goal.”
Maviret is a pangenotypic, 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 orally 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 infected with GT1, 2, 4, 5, or 6. For treatment-naïve patients with compensated cirrhosis and GT3 infection, the recommended duration of Maviret therapy is 12 weeks.
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) infection. 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 chronic hepatitis C virus (HCV) infection of all major genotypes (GT1, 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 clinically urgent overseas new drugs published by the National Medical Products Administration (NMPA) due to its “therapeutic advantages over marketed products.”
Clinical trial data for Maviret demonstrate that in treatment-naïve, non-cirrhotic patients with all major hepatitis C virus genotypes (GT1–6), the virologic cure rate exceeds 99%, with a treatment duration as short as 8 weeks. This regimen does not require co-administration of ribavirin and involves once-daily 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 the need for dose adjustment, achieving virologic cure rates nearing 100% with a favorable safety profile. (Bioon.com)