sofosbuvir 400mg tablet (Sovaldi®)

following a full submission:

sofosbuvir (Sovaldi®) is accepted for restricted use within NHS Scotland.

Indication under review: in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

SMC restriction: Sofosbuvir is accepted for use in patients with genotypes 1 to 6.  Use in treatment-naive patients with genotype 2 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.  Use of the 24-week interferon-free regimen of sofosbuvir in combination with ribavirin in patients with genotype 3 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.

Sofosbuvir in combination with ribavirin, or peginterferon plus ribavirin, produced sustained virological suppression in patients with all genotypes of hepatitis C. It is the first medicine licensed for use in interferon-free regimens and may be associated with improved tolerability compared to standard interferon-based regimens.  

No clinical or economic data were presented for treatment-experienced patients with genotype 1.