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ギリアド・サイエンシズ【GILD】の掲示板 〜2020/04/29
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Vosevi is a fixed-dose combination of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor; velpatasvir (GS-5816), a pan-genotypic HCV NS5A protein inhibitor; and voxilaprevir (GS-9857), a pan-genotypic HCV NS3/NS4A protease inhibitor.
Harvoni is a fixed dose combination of Sovaldi and ledipasvir, an HCV NS5A protein inhibitor.
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European Commission approves Gilead’s HCV triple combo
Gilead Sciences Inc. (NASDAQ:GILD) said the European Commission approved Vosevi sofosbuvir/velpatasvir/voxilaprevir to treat HCV genotypes 1-6 infection in adults.
The drug is approved as a 12-week regimen for patients without cirrhosis or with compensated cirrhosis who previously failed a direct-acting antiviral (DAA)-containing regimen. The EC also approved a 12-week regimen for use in DAA-naïve patients with compensated cirrhosis with an option to shorten therapy to 8 weeks for those infected with genotype 3.
Earlier this month, FDA approved Vosevi for HCV genotypes 1-6 infection in previously treated adults (see BioCentury Extra, July 18).
Separately, the European Commission expanded the indication for Gilead's Harvoni ledipasvir/sofosbuvir to include treatment of HCV genotypes 1,3,4,5 and 6 infection in patients ages 12-18. Harvoni is already approved in adults.