A drug combination widely used off-label to treat hepatitis C (HCV) has been given the nod by the FDA.

The agency approved simeprevir (Olysio) and sofosbuvir (Sovaldi) as a combination for the treatment of chronic genotype 1 HCV, according to Janssen Therapeutics, the maker of simeprevir.

Importantly, the combination can be used without ribavirin or pegylated interferon-alfa, the two drugs that for years were the mainstays of HCV therapy. Both are regarded as difficult to tolerate and sometimes dangerous.


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Simeprevir and sofosbuvir were initially approved within 2 weeks of one another last year, but only sofosbuvir was cleared for use without interferon; in some patients, the FDA said it could be used with ribavirin alone.

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