Promoting Optimum Health & Happiness

   

Sovaldi (sofosbuvir)

Indications and Contraindications

Sovaldi® is indicated for the treatment of genotype 1, 2, 3 or 4 chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.
[Sovaldi® PI 2015 p3 Sec1/A]

Contraindications: [Sovaldi® PI 2015 p4 Sec4/B]

When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to Sovaldi® combination therapy. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

Pharmacology

Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with IC50 values ranging from 0.7 to 2.6 µM. GS-461203 is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. [Sovaldi® PI 2015 p18 Sec12.4/A]

Supplied Form/Description

Sovaldi® is available for oral administration in Gilead Access Operations and Emerging Market (AO&EM) countries as:

  • White-colored, capsule-shaped, film-coated tablet containing 400 mg sofosbuvir debossed with “GSI” on one side and “7977” on the other side

Sovaldi® is packaged as follows:

  • Bottles of 28 tablets [Sovaldi® PI 2015 p29 Sec16 /B]

Storage and Handling: [Sovaldi® PI 2015 p29-30 Sec16 /C]

  • Store at room temperature below 30°C (86°F)
  • Dispense only in original container
  • Do not use if seal over bottle opening is broken or missing