The European Commission has approved US pharma giant Merck & Co’s (NYSE: MRK) Zepatier (elbasvir/grazoprevir) with or without ribavirin (RBV) for the treatment of chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection in adults.
This approval allows marketing of Zepatier tablets in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck continues to work to supply the EU market, with product launches estimated to begin between the fourth quarter of 2016 and the first quarter of 2017. Product launches are expected to continue across the EU through 2017.
“The approval of Zepatier in the European Union, following approvals in the United States and Canada earlier this year, is an important step in offering a new and effective treatment for millions of people infected with hepatitis C virus genotype 1 or 4,” said Dr Roger Perlmutter, president, Merck Research Laboratories, a USA-based division of Merck. “Zepatier is the most recent advance from MSD [Merck & Co’s trading name outside of North America] 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,” he added.
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A good reason to celebrate, say hospital doctors
In India, it is estimated that up to 1.5% of the population has a hepatitis C infection, with certain areas in the Punjab, North East and tribal areas considered possible “hepatitis C virus hotspots”. With a global burden of 130-150 million people, hepatitis C, along with hepatitis B, are among the leading causes of liver cancer and pose a significant health challenge.
The standard of care for hepatitis C has changed over the years. Initially, it was only injectable interferon. Later, combinations of injectable interferon or pegylated interferon with ribavirin and protease inhibitors were introduced. More recently, the World Health Organization has recommended that newer oral agents called direct antiviral agents (DAA) be included for all patients with hepatitis C. DAAs have been found to be better tolerated, safer, need to be taken for a shorter time and are more effective.
Dr. Samir Shah, Head, Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospitals,Mumbai recently presented the results from a 14-centre study across India where a DAA, sofosbuvir, was used in an interferon-free combination with ribavirin, for 117 treatment-naïve patients with chronic hepatitis C infections. “We found that this regimen was more effective in our Indian patients than the reports from the West,” he said.
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End Hep C SF is a multi-sector collective impact* initiative that utilizes evidence-based practices, community wisdom, and the creative leveraging of resources to work toward hepatitis C elimination in San Francisco. San Francisco has a history of innovative and ambitious public health efforts. End Hep C SF emerges from that history to tackle an epidemic that kills more Americans than the deaths from sixty other reportable infectious diseases, including HIV, pneumococcal disease, and tuberculosis, combined.
San Francisco is impacted profoundly by the hepatitis C virus (HCV), a communicable liver disease that is a significant driver of morbidity, liver cancer, and death.
The availability of highly effective, well-tolerated oral HCV therapy gives us the remarkable ability to cure HCV in nearly all people living with the virus. We now have the tools to greatly reduce the negative health consequences of HCV, to break the cycle of forward transmission through cure as prevention, and to ultimately eliminate HCV in San Francisco.
To realize the potential of modern HCV therapy, we have established End Hep C SF. Our long-term strategic plan is to lay the foundation for HCV elimination in San Francisco through a comprehensive approach based on three pillars.
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