Gilead Sciences has announced that the Marketing Authorization Application ( MAA ) for the investigational, once-daily, single tablet regimen of Sofosbuvir 400 mg, Velpatasvir 100 mg and Voxilaprevir 100 mg ( SOF/VEL/VOX ) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency ( EMA ).

The MAA for SOF/VEL/VOX is supported by data from two phase 3 studies ( POLARIS-1 and POLARIS-4 ), which evaluated 12 weeks of the fixed-dose combination in direct-acting antiviral (DAA)-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A inhibitor-containing regimen.

Across the two studies, 97% of patients treated with SOF/VEL/VOX ( n=430/445 ) achieved the primary efficacy endpoint of SVR12.
The MAA has also included data from two additional phase 3 studies ( POLARIS-2 and POLARIS-3 ), which evaluated 8 weeks of SOF/VEL/VOX in 611 DAA-naïve patients with genotypes 1-6.
In POLARIS-3, 96% of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX ( n=106/110 ) achieved the primary efficacy endpoint of SVR12.
The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest. ( Xagena )

Source: Gilead Sciences, 2017