following a full submission
daclatasvir (Daklinza®) is accepted for restricted use within NHS Scotland.
Indication under review: In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.
SMC restriction: use is restricted to patients with significant fibrosis (Metavir scores F3-F4) or compensated cirrhosis.
In a phase II study 89% to 99% of patients with genotype 1 and 3 HCV treated with daclatasvir in various peginterferon-free regimens achieved a sustained virological response at 12 weeks (SVR12). In a phase III study of patients with genotype 4 HCV, the superiority of daclatasvir with peginterferon-alfa plus ribavirin (PR) versus placebo + PR was demonstrated for the primary endpoint of SVR12.
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Medicine details
- Medicine name:
- daclatasvir (Daklinza)
- SMC ID:
- 1002/14
- Indication:
- In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.
- Pharmaceutical company
- Bristol-Myers Squibb Pharmaceuticals Ltd
- BNF chapter
- Infections
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 10 November 2014