You are here:

sofosbuvir 400mg tablet (SovaldiĀ®)

Advice

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.
 

Drug Details

Drug Name: sofosbuvir 400mg tablet (SovaldiĀ®)
SMC Drug ID: 964/14
Manufacturer: Gilead Sciences Ltd
Indication: in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
BNF Category:
Sub Category: 5.3 Antiviral Drugs
Submission Type: Full submission
Status: Accepted
Date Advice Published: 9 June 2014

Back