Sofosbuvir

1).

1). 1.

SOVALDI is indicated for the treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus (CHC) infection as a component of a combination antiviral treatment regimen. The following points should be considered when initiating treatment with SOVALDI:  SOVALDI must not be administered as monotherapy (see 7 WARNINGS AND PRECAUTIONS, General).

 Treatment regimen and duration are dependent on both viral genotype and patient population (see 4 DOSAGE AND ADMINISTRATION).  Treatment response varies based on baseline host and viral factors. Patients Awaiting Liver Transplantation Efficacy with SOVALDI + ribavirin (RBV) regimen has been established in patients with HCV genotype 1, 2, 3 or 4 infection awaiting liver transplantation with hepatocellular carcinoma (HCC) meeting Milan criteria (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).

Patients Co-infected with Human Immunodeficiency Virus (HIV-1) Efficacy with SOVALDI + RBV regimen has been established in treatment-naïve CHC patients with HCV genotype 1 and in CHC patients with HCV genotype 2 or 3 regardless of treatment experience.

2) and Clinical Studies (14) ]: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. 2 , 14 ): genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.

genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.