Holkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir), developed by AbbVie, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.
Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) compares the drug’s clinical and cost-effectiveness to those of other treatments. This assessment report is then sent to the provinces and territories to help them decide on coverage.
The CDEC’s Final Recommendation advocates for Holkira Pak to be listed as a treatment for adults with genotype 1 hep C if the following criteria is met:
- Patients must have a liver fibrosis stage of F2 or greater before they are eligible for PharmaCare coverage.
- Treatment should be started by physicians experienced with treating chronic hep C.
- Drug plans should not pay more for Holkira Pak than they do for other hep C interferon-free treatments.
Reasons for the Holkira Pak Recommendations
- 6 randomized clinical trials (Sapphire I, Sapphira II, Pearl II, Pearl III, Pearl IV, and Turquoise II) showing that treatment with Holkira Pak, with or without ribavirin (RBV), achieved high rates of SVR12 (cure at 12 weeks) for both those who have and those who haven’t already tried treatment.
- Holkira Pak’s results (quality-adjusted life years) and costs are similar to other hep C treatments, such as Harvoni. Provinces will have to consider drug plan and health care system sustainability when deciding whether or not to cover newly available expensive hep C treatments.
- CDEC couldn’t evaluate the cost-effectiveness of Holkira Pak according to liver fibrosis stage due to limitations in the manufacture’s pharmacoeconomic evaluation.
Other Reported Discussion Points
- Holkira Pak may offer a greater range of therapeutic options to some patients, but it requires more pills be taken than Harvoni.
- There may be a greater chance of drug interactions while taking Holkira Pak than while taking Harvoni.
- A phase 2 clinical trial (TURQUOISE I) tested hep C patients co-infected with HIV with 12 or 24 weeks of Holkira Pak and ribavirin (RBV). SVR12 rates were 93.5% and 90.6% for the 12 and 24 week groups.
Reported Research Gaps
- There isn’t a comparison between Holkira Pak and Harvoni.
- The consequences of reinfection following treatment with hep C direct-acting antiviral require further study.
Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, short-course, interferon-free treatment that can be taken with or without ribavirin.
In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).