Gilead Sciences drug combination clears hepatitis C in all patients in Phase II trial

Shares in Gilead Sciences rose as much as 12 percent Monday after the company reported data from a mid-stage trial at the AASLD annual meeting suggesting that its experimental hepatitis C drugs cleared the virus in 100 percent of treatment-naïve patients. "This is starting to look like a home-run as we now know [Gilead] at least has a 100 percent cure all-oral regimen with its own wholly-owned drug with no partnering," remarked RBC Capital Markets analyst Michael Yee.

In the ELECTRON trial, 25 patients with hepatitis C virus (HCV) genotype 1 were treated with an oral regimen of sofosbuvir, GS-5885 and ribavirin for 12 weeks. In addition to achieving a sustained virological response (SVR) four weeks after completing therapy, the company reported that the drug combination was well tolerated. In a subset of the trial, nine previous null responders were treated with this same combination and the virus was not detected in the three patients who have reached the four-week post-treatment time point. "These results indicate that adding GS-5885 to sofosbuvir-based regimens may enhance SVR rates, potentially offering HCV genotype 1 infected patients a convenient 12-week course of oral therapy," remarked principal study investigator Edward Gane.

Gilead recently initiated a Phase III trial evaluating sofosbuvir and GS-5885 without ribavirin in 800 HCV genotype 1 treatment-naïve patients, 20 percent of whom have evidence of cirrhosis. The four-arm study will evaluate 12- and 24-week courses of the combination therapy.

At the same meeting, Abbott announced that a trio of its medications used in combination with ritonavir cleared the virus in 97.5 percent of treatment-naïve patients and produced "unprecedented" cure rates for patients who failed to benefit from standard treatment. However, Piper Jaffray & Co. analyst M. Ian Somaiya indicated that it was "a clear disadvantage" for Abbott that its regimen requires more drugs than Gilead's planned combination therapy.

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