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European Commission Approves Zepatier for HCV Genotypes 1, 4

Merck announced the European Commission granted marketing authorization for Zepatier to treat adult patients with chronic hepatitis C virus genotype 1 and 4 infection, with or without ribavirin, according to a company news release.

Zepatier (grazoprevir/elbasvir, Merck), a once-daily, fixed-dose combination tablet containing 100 mg grazoprevir, an NS3/4A protease inhibitor, and 50 mg elbasvir, an NS5A inhibitor, was approved for a treatment duration of 12 or 16 weeks, depending on HCV genotype and prior treatment history. For patients with HCV genotype 1a, 1b and 4, a 12-week, once-daily regimen is recommended. In patients with genotype 1a with HCV RNA levels greater than 800,000 IU/mL and NS5A polymorphisms, a 16-week regimen with ribavirin is recommended. In patients with genotype 4 with HCV RNA levels greater than 800,000 IU/mL, a 16-week regimen plus ribavirin is recommended, according to the release.

The authorization allows for the combination regimen to be marketed in all 28 EU countries, as well as in Iceland, Liechtenstein and Norway.

“Given the complexities of chronic hepatitis C, it is critical to have a variety of effective treatment options to ensure diverse types of patients have the highest possible chance to achieve cure,” Rafael Esteban, MD, chief of internal medicine and the liver unit at the Hospital Universitario Val d’ Hebron, Barcelona, Spain, said in the release.

The approval is indicative of clinical data from the C-EDGE COINFECTION, C-EDGE TN, C-EDGE TE, C-WORTHY, C-SURFER, C-SCAPE, C-SALVAGE and C-EDGE CO-STAR clinical trials, in which nearly 2,000 patients with various chronic HCV genotypes, including treatment-naive patients, nonresponders to prior therapy, those with compensated cirrhosis or HIV-1 coinfection, were dosed with the combination regimen and reached high sustained virologic response at 12 weeks after completed therapy.

“Zepatier is the most recent advance from [Merck] in our more than 30-year effort to combat the effects of hepatitis C virus infection, and hence, to reduce the burden of this disease around the world,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in the release.

The FDA approved Zepatier in January after re-establishing two new designations in April 2015 for the combination regimen for patients with HCV genotypes 1 and 4 with end-stage renal disease on hemodialysis after rescinding breakthrough designation earlier last year. The FDA originally granted breakthrough therapy designation for the drug combination in October 2013. However, in February 2015, Merck announced the FDA’s intent to rescind that designation due to the availability of other new drugs for HCV.

Disclosure: Perlmutter is employed by Merck. Infectious Disease News was unable to confirm relevant financial disclosures for Esteban at the time of publication.

Merck announced the European Commission granted marketing authorization for Zepatier to treat adult patients with chronic hepatitis C virus genotype 1 and 4 infection, with or without ribavirin, according to a company news release.

Zepatier (grazoprevir/elbasvir, Merck), a once-daily, fixed-dose combination tablet containing 100 mg grazoprevir, an NS3/4A protease inhibitor, and 50 mg elbasvir, an NS5A inhibitor, was approved for a treatment duration of 12 or 16 weeks, depending on HCV genotype and prior treatment history. For patients with HCV genotype 1a, 1b and 4, a 12-week, once-daily regimen is recommended. In patients with genotype 1a with HCV RNA levels greater than 800,000 IU/mL and NS5A polymorphisms, a 16-week regimen with ribavirin is recommended. In patients with genotype 4 with HCV RNA levels greater than 800,000 IU/mL, a 16-week regimen plus ribavirin is recommended, according to the release.

The authorization allows for the combination regimen to be marketed in all 28 EU countries, as well as in Iceland, Liechtenstein and Norway.

“Given the complexities of chronic hepatitis C, it is critical to have a variety of effective treatment options to ensure diverse types of patients have the highest possible chance to achieve cure,” Rafael Esteban, MD, chief of internal medicine and the liver unit at the Hospital Universitario Val d’ Hebron, Barcelona, Spain, said in the release.

The approval is indicative of clinical data from the C-EDGE COINFECTION, C-EDGE TN, C-EDGE TE, C-WORTHY, C-SURFER, C-SCAPE, C-SALVAGE and C-EDGE CO-STAR clinical trials, in which nearly 2,000 patients with various chronic HCV genotypes, including treatment-naive patients, nonresponders to prior therapy, those with compensated cirrhosis or HIV-1 coinfection, were dosed with the combination regimen and reached high sustained virologic response at 12 weeks after completed therapy.

“Zepatier is the most recent advance from [Merck] in our more than 30-year effort to combat the effects of hepatitis C virus infection, and hence, to reduce the burden of this disease around the world,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in the release.

The FDA approved Zepatier in January after re-establishing two new designations in April 2015 for the combination regimen for patients with HCV genotypes 1 and 4 with end-stage renal disease on hemodialysis after rescinding breakthrough designation earlier last year. The FDA originally granted breakthrough therapy designation for the drug combination in October 2013. However, in February 2015, Merck announced the FDA’s intent to rescind that designation due to the availability of other new drugs for HCV.

Disclosure: Perlmutter is employed by Merck. Infectious Disease News was unable to confirm relevant financial disclosures for Esteban at the time of publication.