Harvoni, created by Gilead Sciences, passed its Common Drug Review this week with the Canadian Drug Expert Committee (CDEC)’s Final Recommendation. The CDEC’s Final Recommendation advocates that Harvoni, ledipasvir/sofosbuvir, be listed for the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults. It recommended 3 conditions for this.
The 3 conditions recommended by the Canadian Drug Expert Committee were:
- Liver fibrosis be at stage 2 or higher
- Treatment should be initiated by physicians experienced with treating chronic hep C
- A substantial reduction in price
Reasons for the Recommendations were:
- 3 clinical trials (ION-1, ION-2, and ION-3) showing that treatment with Havoni, with or without ribavirin (RBV), achieved high rates of SVR12 (cure at 12 weeks) for both those who have and those who haven’t tried treatment.
- The treatment’s cost was deemed cost-effective when compared with Sovaldi (sofosbuvir) and Galexos (simeprevir) in combination with pegylated interferon and ribavirin (PR). This was for those who have and haven’t tried treatment and for those who have without cirrhosis.
The CDEC’s report also covered such information as the treatment’s background, efficacy, side effects, and cost and cost-effectiveness.
When I read the report, I found an interesting note under “Other Discussion Points”. It said that although the ION trials didn’t look at patients coinfected with HCV and HIV, the committee did and cited that ERADICATE, a recently completed trial, demonstrated similar SVR12 rates (98%) in patients coinfected with HCV and HIV to those reported in the three ION trials.