Gilead Sciences, Inc. (GILD), Wednesday announced topline results from three late-stage trials, ION-1, ION-2 and ION-3 studying the investigational once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir or SOF 400 mg and the NS5A inhibitor ledipasvir or LDV 90 mg, with and without ribavirin or RBV, for the treatment of genotype 1 chronic hepatitis C virus or HCV infection.
In the studies, 1,952 patients with genotype 1 HCV infection were randomized to receive SOF/LDV with or without RBV for eight, 12 or 24 weeks of therapy. Of the 1,518 patients randomized to the 12-week arms of ION-1 and to all arms of ION-2 and ION-3, 1,456 patients met the primary efficacy endpoint of SVR12. Of the 62 patients who failed to meet the endpoint, 36 faced virologic failure, while 26 patients lost to follow-up or withdrew consent.
The FDA has granted the SOF/LDV fixed-dose combination a Breakthrough Therapy status. Sofosbuvir was approved as Sovaldi in the U.S. and Canada few days ago. Applications are pending in the European Union, Australia and New Zealand, Switzerland and Turkey.
"With the availability of these results, Gilead is finalizing its regulatory filing for sofosbuvir/ledipasvir, with the goal of submitting a New Drug Application in the first quarter of 2014." said the Executive Vice President of Research and Development and Chief Scientific Officer.
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