Gilead's (GILD) Sofosbuvir has Favorable Risk-Benefit on HCV

October 23, 2013 8:11 AM EDT
The FDA said Gilead Sciences' (Nasdaq: GILD) Sofosbuvir has a favorable risk-benefit on hepatits C (HCV). From an Antiviral Drugs Advisory Committee Meeting background package submitted today:

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.

The full background package can be accessed here.


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