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On October 29th, we learned that Simeprevir (tradename GALEXOS in Canada or OLYSIO in the USA) will now be reimbursed by BC PharmaCare. This drug is a great addition to the hepatitis C “medicine cabinet” and now that it is covered, BC’s patients most in need of this treatment will now be able to afford it. It would appear that this drug will probably replace two drugs with significant side-effects, boceprevir (VICTRELIS) and telaprevir (INCIVEK) in BC. We are not overjoyed at this news, however, as it comes with some downsides.
First, simeprevir is not being offered as a stand-alone drug which could be used in a “cocktail” with other drugs. It is only being covered if used in combination with interferon and ribavirin, two drugs most HCV+ people are very anxious to avoid (particularly interferon). For example, Medivir is studying the combination of simeprevir with daclatasvir and sofosbuvir in people with genotypes 1 and 4 (http://finance.yahoo.com/news/medivir-phase-ii-impact-study-121300504.html ). These three powerful Direct Acting AntiVirals, from three different companies, could be a super-cure, but Health Canada’s recent approvals of hepatitis C drugs usually limit their use to particular combinations, which means any additional combinations with that same drug must go through an entire new approval process consuming substantial time and money (adding to the eventual cost of the drug).
Second downside is the very restrictive list of access criteria:
- Genotype 1 ONLY
- EITHER no cirrhosis OR compensated cirrhosis (no de-compensated cirrhosis)
- EITHER treatment-naïve OR treatment-experienced patients who are prior relapsers, partial responders or null responders.
- Fibrosis stage F2 or greater on Metavir scale, determined through biopsy, Fibroscan, or serum biomarker panel (such as APRI).
- Patient has NEVER been treated with a HCV NS3/4A protease inhibitor (such as boceprevir [VICTRELIS] or telaprevir [INCIVEK])
- Patient is not currently being treated with an NS5A/NS5B inhibitor (such as daclatasvir, sofosbuvir, ABT-267, PPI-668, or ledipasvir).