Since identifying the hepatitis C virus (HCV) in 1989, scientists have attributed it with causing more than 500,000 deaths worldwide each year. Millions more suffer with chronic symptoms.
HCV can damage the liver. Infection begins as acute hepatitis C, and while the virus can run its course through the body with no lasting consequence, approximately 75% of those infected will go on to develop chronic hepatitis C. Many individuals are unaware that they carry the virus. See more information in our infographic.
The good news is that research has resulted in new combination medications that have catapulted hepatitis C treatment from managing the infection to curing it. Remarkably, these medications are easy to take, have shorter treatment duration, fewer side effects, and are highly effective, curing more than 90% of cases. Current therapy to cure hepatitis C relies on medications taken for 8-48 weeks, depending on the particular patient and viral genotype.
After a drug is approved for use (receives Notice of Compliance or NOC) by Health Canada – based on evidence supporting its safety and efficacy – it goes before the Common Drug Review (CDR), which is the body that looks at health technology and cost-effectiveness of drugs and devices on behalf of the public drug programs (except Quebec).
Harvoni® received NOC on 2014-10-15 and Holkira™ PAK on 2014-12-22 for Hepatitis C. This means that they are now available for sale in Canada and that many private drug plans are already covering them. However, for coverage (listing) by public drug plans (formularies) the medications must go through a secondary review process at the CDR. When these drugs go before the CDR, the GI Society and other patient groups prepare patient impact submissions to be sure the reviewers consider patient-level concerns.
The results from the CDR have been favourable for Harvoni®, and Holkira™ PAK is undergoing a rapid review. Currently, most Canadian public plans are covering Harvoni® and we look forward to similar availability for Holkira™ PAK once it moves through the system. It makes sense to us, and to the patients who we represent, that when a medication is available that offers a cure, the person with the disease should have reasonable access. Both those groups who have not responded to previous treatment and those who are naive to treatment should be able to have the opportunity for a cure.
The hepatitis C virus replicates by using proteins to make copies of itself. These new therapies attack the hepatitis C virus by directly inhibiting proteins that are vital to the virus’s ability to replicate. Many different direct acting antivirals (DAAs) with unique mechanisms of action are now available for use either in combination, with or without ribavirin, and in some cases with pegylated interferon as well.
Sovaldi® (sofosbuvir) is an NS5B nucleotide polymerase inhibitor, taken orally as a single tablet, once daily. It is used in combination with ribavirin alone for treatment durations of 12 to 24 weeks (in genotypes 2 and 3), or with pegylated interferon and ribavirin for 12 weeks (in genotypes 1, 2, and 3).
Harvoni® (sofosbuvir/ledipasvir) is a combination of ledipasvir, an NS5A inhibitor, which has been co-formulated with sofosbuvir into an all-oral single-tablet regimen, taken once a day. This regimen, when taken for 8 to 24 weeks, is currently widely used in Canada for genotype 1 disease with emerging data in other genotypes.
Holkira™ PAK (Ombitasvir/paritaprevir/ritonavir and dasabuvir) is an all-oral combination of three DAAs plus ritonavir, taken as 4 pills divided into twice daily dosing. The regimen includes an NS3 protease inhibitor, an NS5A inhibitor, and a non-nucleotide NS5B polymerase inhibitor. It is used with or without ribavirin for a treatment duration of 12 (most individuals) or 24 weeks depending on the individual patient. In Canada, it is approved and widely used for genotype 1 individuals only, although there are data in other genotypes.