Gilead Sciences reports positive data from four hepatitis C drug trials

Gilead Sciences has announced clinical data showing the benefits of their new combination therapy for hepatitis C virus (HCV) infections.

Topline results from four international phase III clinical studies – POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4 – have been presented, showing how a fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir can enhance the treatment of genotype 1 to 6 HCV infections.

In POLARIS-1 and POLARIS-4, 445 patients with genotype 1-6 HCV infection who were previously treated with direct-acting antiviral agents (DAAs) received 12 weeks of treatment with the new combination therapy, experiencing high cure rates.

Meanwhile, POLARIS-2 and POLARIS-3 showed similar benefits among 611 patients who were not previously treated with a DAA and received eight weeks of therapy with the combination regimen.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead Sciences, said: "The POLARIS study results demonstrate that combining three potent antivirals with different mechanisms of action and high barriers to resistance can provide high cure rates for patients who have failed other highly effective oral DAA regimens."

Based on these findings, the company will submit regulatory applications for this regime for the treatment of chronic HCV in the US in the fourth quarter of 2016, with a European submission coming shortly afterwards.

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