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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)] .
There is currently no drug history available for this drug.
SOVALDI is the brand name for sofosbuvir, a nucleotide analog inhibitor of HCV NS5B polymerase.
The IUPAC name for sofosbuvir is ( S)-Isopropyl 2-(( S)-(((2 R,3 R,4 R,5 R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2 H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate. It has a molecular formula of C 22H 29FN 3O 9P and a molecular weight of 529.45. It has the following structural formula:
Sofosbuvir is a white to off-white crystalline solid with a solubility of ≥ 2 mg/mL across the pH range of 2–7.7 at 37 °C and is slightly soluble in water.
SOVALDI tablets are for oral administration. Each tablet contains 400 mg of sofosbuvir. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose. The tablets are film-coated with a coating material containing the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.