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Direct-Acting Antivirals for Chronic Hepatitis C Genotype 1

Published on: October 3, 2014
Project Number: TR0007
Product Line: Therapeutic Review
Result type: Report

Note: This therapeutic review was conducted in 2014 and there is now an update in progress. Refer to the current therapeutic review, as well as a large number of other reports, bundled together in our Summary of CADTH Resources.

CADTH has examined the clinical and economic impact of new and existing drugs to treat chronic hepatitis C virus (HCV) infection.

Treatment of HCV has remained unchanged for many years, with standard therapy being pegylated interferon plus ribavirin. There are some challenges with interferon therapy, including side effects and the need to administer injections. In 2011, the first direct-acting antiviral agents (DAAs) were approved for use in Canada, in combination with standard therapy.

In 2014, new oral agents were continuing to emerge, with the possibility of interferon-free regimens on the horizon. A Therapeutic Review focused on regimens approved in Canada at the time of writing. As of fall 2014, this meant that only treatment regimens that included pegylated interferon plus ribavirin were considered.

The project had two key components :

  • A comparison of the clinical and cost-effectiveness of drug therapies for chronic HCV infection.
  • The development of recommendations or advice from the Canadian Drug Expert Committee (CDEC).

Patient Input

The Canadian Agency for Drugs and Technologies in Health is piloting the inclusion of patient group input in its process for the therapeutic review of direct-acting antivirals for chronic hepatitis C genotype 1.

The submitted patient group input identifies health outcomes and issues of importance to patients, and their unmet needs in managing chronic hepatitis C. The patient input is systematically incorporated into this therapeutic review, beginning with informing the project protocol through to informing the Canadian Drug Expert Committee in making its recommendation(s) based on this therapeutic review.

Below are links to the patient group input that was submitted for this project. Documents have not been summarized, edited, or critically appraised — they are posted in the format in which they were received.

Key Messages

Triple therapy with a DAA plus pegylated interferon and ribavirin (PR) treatment should be offered only to patients who:

  • are treatment-naive or have been successfully treated but have now relapsed
  • have moderate to severe fibrosis (Metavir score F2, F3, or F4).

People who have been previously treated with DAA plus PR triple therapy and had a partial or no response should not be re-treated with another DAA plus PR regimen.

Simeprevir is the drug of choice among the protease inhibitors (boceprevir, telaprevir, and simeprevir).

No recommendation can be made regarding the place in therapy for sofosbuvir.