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FDA panel says Gilead hepatitis C drug has 'favorable benefit-risk'

In briefing documents ahead of Friday's meeting, an FDA panel said of Gilead’s sofosbuvir, "The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C. In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen. In addition, SOF+RBV provides a therapeutic option for patients who are ineligible, intolerant or unwilling to take interferon-based regimens, thus addressing an unmet need in this patient population...No major safety issues associated with sofosbuvir use have been identified to date."