You are here:

daclatasvir (Daklinza)

Advice

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. 

Drug Details

Drug Name: daclatasvir (Daklinza)
SMC Drug ID: 1002/14
Manufacturer: Bristol-Myers Squibb Pharmaceuticals Ltd
Indication: In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.
BNF Category:
Submission Type: Full submission
Status: Restricted
Date Advice Published: 10 November 2014

Back