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The Committee for Medicinal Products for Human Use ( CHMP ), of the European Medicines Agency ( EMA ), has adopted a positive opinion for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor Sofosbuvir 400 mg and Velpatasvir 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus ( HCV ) infection.
The data included in the application support the use of Epclusa in adults with all genotypes ( GT1-6 ) of HCV infection.

The MAA ( Marketing Authorization Application ) for Epclusa is supported by data from four phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.
In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis ( Child-Pugh A ) received 12 weeks of Epclusa.
The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis ( Child-Pugh B ) to receive 12 weeks of Epclusa with or without Ribavirin ( RBV ) or 24 weeks of Epclusa.
The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy ( SVR12 ).

Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 ( 98% ) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate ( 94% ) compared to those who received Epclusa for 12 weeks or 24 weeks without Ribavirin ( 83% and 86%, respectively ).
The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1. ( Xagena )

Source: Gilead, 2016

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