Hepatology
View Abstract - Benefit-Risk Assessment for Sofosbuvir/Velpatasvir/Voxilaprevir Based on Patient Population and HCV genotype: FDA's Evaluation
FDA scientists provide rationale behind Vosevi indications
Last Updated: 2017-11-23
By Reuters Staff
NEW YORK (Reuters Health) - Food and Drug Administration (FDA) scientists explain why the indication for Vosevi is narrower for NS5A inhibitor-naive hepatitis C virus (HCV) patients in a new report.
The FDA approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in July 2017, stating that the fixed-dose combination (FDC) was indicated for patients with genotype 1, 2, 3, 4, 5, or 6 HCV infection treated previously with NS5A inhibitor-containing regimens. But in patients not exposed to NS5A inhibitors who had taken sofosbuvir previously, SOF/VEL/VOX was only indicated for patients with genotype 1a or 3 HCV, the authors explain in Hepatology, online October 23.
Continue to article - http://www.chronicliverdisease.org/reuters/article.cfm?article=20171123Other1376567288
By Reuters Staff
NEW YORK (Reuters Health) - Food and Drug Administration (FDA) scientists explain why the indication for Vosevi is narrower for NS5A inhibitor-naive hepatitis C virus (HCV) patients in a new report.
The FDA approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in July 2017, stating that the fixed-dose combination (FDC) was indicated for patients with genotype 1, 2, 3, 4, 5, or 6 HCV infection treated previously with NS5A inhibitor-containing regimens. But in patients not exposed to NS5A inhibitors who had taken sofosbuvir previously, SOF/VEL/VOX was only indicated for patients with genotype 1a or 3 HCV, the authors explain in Hepatology, online October 23.
Continue to article - http://www.chronicliverdisease.org/reuters/article.cfm?article=20171123Other1376567288
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