Gilead Sciences Offers New Hep B Treatment
August 19, 2008
Produced by the Foster City-based Gilead Sciences, the once-daily tablet Viread has been granted marketing approval for the treatment of chronic hepatitis B (HBV) by the U.S. Food and Drug Administration, the biopharmaceutical company announced Aug. 11.
The tablet works by blocking HBV DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells. It has been available in the U.S. as a treatment originally for HIV infection in adults since 2001. Research into the drug’s effect on HBV began after physicians noted Viread had an affect on HIV- and HBV-infected patients.
Clinical trials showed that the drug is also able to treat adults with chronic hepatitis B. Studies show that a significantly greater percentage of patients with chronic hepatitis B who received Viread achieved a complete response to treatment compared to those who received Hepsera, the most widely prescribed chronic hepatitis B oral treatment in the U.S., also produced by Gilead Sciences.
“Viread has the potential to have a huge impact on the treatment of chronic hepatitis B given its potency, safety, low resistance and pricing,” said Dr. Eddie Cheung, clinical professor of Internal Medicine and Gastroenterology/Hepatology at the UC Davis School of Medicine.
Viread has been approved for the treatment of chronic hepatitis B in the European Union, Turkey, Australia and New Zealand earlier this year, and a marketing application is currently pending in Canada.
“The approval of Viread for hepatitis B represents more than a decade of work in both the fields of HIV and hepatitis B to develop a medication that offers significant viral suppression,” said Kevin Young, executive vice president of Commercial Operations at Gilead Sciences. “We look forward to partnering with community members to increase disease awareness and expand access to treatment for those patients in need.”
Carol Brosgart, MD, vice president of Public Health and Policy at Gilead Sciences, said in order to market this product to the Asian American community, which is disproportionately affected by the disease, the company developed both in-language disease awareness materials and an informational website (AsianLiver.com) to provide patients with accurate information about the disease, risk factors, testing and treatment. She said they are also placing prominent print and billboard advertising in large Asian markets including the Bay Area and New York City, to ensure that patients are aware of the impact of hepatitis B on the Asian community.
Brosgart said that while there is no simple cure for chronic hepatitis B, treatment can help reduce the virus amount and the potential for liver disease or liver injury.
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For more information about Viread: viread.com. For more on Gilead Sciences: gilead.com. For more about the S.F. Hep B Free campaign: sfhepbfree.org.
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