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SOVALDI(sofosbuvir) tablets, for oral use
2014-12-09 23:10:34 来源: 作者: 【 】 浏览:526次 评论:0

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI.

SOVALDI® (sofosbuvir) tablets, for oral use

Initial U.S. Approval: 2013

INDICATIONS AND USAGE
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. (1)

•SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. (1)
DOSAGE AND ADMINISTRATION
•One 400 mg tablet taken once daily with or without food. (2.1)
•Should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC. Recommended combination therapy: (2.1)

•SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible.

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