FDA approves Harvoni for HCV treatment
Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration.
Treatment-naive participants showed a 94% sustained virologic response rate after 8 weeks of treatment and a 96% SVR rate after 12 weeks. Treatment-naive patients with and without cirrhosis showed a 99% SVR rate after 12 weeks. Among treatment-experienced participants with and without cirrhosis, ribavirin did not improve response rates in any of the trials.
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