Final Recommendation for Daklinza (daclatasvir)

Daklinza (daclatasvir)Daklinza (generic name daclatasvir), developed by Bristol-Myers Sqibb, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

The Canadian Drug Expert Committee (CDEC) Final Recommendation is important within the Canadian drug approval process as it is sent to the provinces and territories to help them decide on PharmaCare coverage.

The CDEC’s Final Recommendation advocates for Daklinzain combination with Sovaldi (sofosbuvir) to be listed as a treatment for adults with chronic hepatitis C genotype 1, 2, or 3 if the following criteria is met:
Clinical Criteria
  • Treatment experienced patients without cirrhosis who have not responded to pegylated interferon with ribavirin (PR).
    The report highlighted that this does not mean that patients who haven’t been treated, are treatment-naive, should be treated with pegylated interferon with ribavirin (PR) first.
  • Treatment should be started by hepatologists or physicians experienced with treating chronic hep C.

  • Drug plans should not pay more for Daklinza than they do for Sovaldi (sofosbuvir) plus ribavirin.

Reasons for the Daklinza Recommendations
  1. The clinical trial ALLY-3 results showed high rates of sustained virologic response (SVR12), cure, for treatment experienced patients with chronic hep C genotype 3.

  2. The manufacturer’s pharmacoeconomic evaluation showed that Daklinza plus Sovaldi was a cost-effective option, when it was compared with 24 weeks of Sovaldi plus ribavirin for patients with hep C genotype 3 who are treatment experienced and don’t have liver cirrhosis. However, Daklinza plus Sovaldi was not a cost-effective option for patients with hep C genotype 3 who are treatment naive and/or have cirrhosis.

Reported Research Gaps
  • There aren’t any comparisons between Daklinza and sofosbuvir and the other hep C direct-acting antivirals that are currently used in Canada.
  • There is limited data on patients who have cirrhosis, are co-infected with other diseases, such as AIDS, or who have been treated with other hep C direct-acting antivirals but who weren’t cured.
Other Highlighted Information
  • Four groups responded to CADTH’s call for input from patient groups. This input successfully explained what it’s like to have hep C, what stigma surrounds hep C, what side effects are like, and the importance of having access to inferferon free/low toxicity treatments with shorter treatment durations and no drug interactions.
Daklinza (daclatasvir)

Daklinza is approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.

Daklinza with Sovaldi is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.