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DAKLINZA (daclatasvir), direct-acting antiviral

INFECTIOLOGY - New medicinal product
Opinions on drugs - Posted on Mar 06 2015

Reason for request

Inclusion

Minor improvement in the treatment of adults infected with genotype 1, 3 and 4 hepatitis C virus (HCV)

 

  • DAKLINZA has Marketing Authorisation in combination with other medicinal products for the treatment of chronic hepatitis C in adults infected with HCV.
  • In combination with sofosbuvir, daclatasvir may provide a cure for the majority of patients with hepatitis C, with or without extrahepatic manifestations.  Daclatasvir treatment should be offered as a priority in all patients whose hepatic disease is at fibrosis stage F3 or F4 and in certain special populations. Patients at fibrosis stage F2 should also receive new treatments within a short time. For F0 or F1 patients, treatment may be delayed depending on the progression of the disease and the patient's background.
  • DAKLINZA provides a minor therapeutic advance in the treatment of genotype 1, 3 and 4 chronic hepatitis C given:

- the level of virological efficacy in patients infected with genotype 4 HCV of daclatasvir + peginterferon/ribavirin, which is greater than that of peginterferon/ribavirin, but less than that described with sofosbuvir + peginterferon/ribavirin,

- the satisfactory safety profile,

- the possible use without interferon in combination with sofosbuvir (with or without ribavirin) in genotype 1, 3 and 4 patients, on the basis of clinical data with a non-optimal level of evidence,

- the significant risk of developing resistance in the event of treatment failure.


Actual benefit

Important

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Improvement in actual benefit

IV (mineur)

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Therapeutic use

-

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