Gilead’s hepatitis C drug meets phase 3 goals

Hannah Blake

pharmaphorum

Phase 3 clinical trials of Gilead Sciences’ experimental hepatitis C drug, sofosbuvir, have produced top line results.

The Phase 3 FUSION study was evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.

The company has announced that the study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25%. In FUSION, 50% of patients (n=50/100) in the 12-week arm and 73% of patients (n=69/95) in the 16-week arm achieved SVR12 (p&lt,0.001 for both arms).

“This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options. With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter.”

Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer.

Economist-pharma-summit-2013

Related news:

Gilead hepatitis C drug meets goal of fourth late-stage study (Reuters)

Reference links:

Gilead press release 

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