Sofosbuvir indications and usage

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Sofosbuvir
SOVALDI ® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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.

  • 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 [See Dosage and Administration (2), Use in Specific Populations (8) and Clinical Studies (14)].

The following points should be considered when initiating treatment with SOVALDI:

  • Monotherapy of SOVALDI is not recommended for treatment of CHC.
  • Treatment regimen and duration are dependent on both viral genotype and patient population [See Dosage and Administration (2)].
  • Treatment response varies based on baseline host and viral factors [See Use in Specific Populations (8) and Clinical Studies (14)].[1]

References

  1. "SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]". Retrieved 7 January 2014.

Adapted from the FDA Package Insert.