Sunvepra (generic name asunaprevir), developed by Bristol-Myers Sqibb, passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.
The Canadian Drug Expert Committee Final Recommendation is important within the Canadian drug approval process as it’s sent to the provinces and territories to help them decide on how they want to cover the treatment through their PharmaCare plans.
The CDEC Final Recommendation for Sunvepra (asunaprevir) when combined with Daklinza (daclatasvir)
The CDEC advocates that Sunvepra, in combination with Daklinza (daclatasvir), be listed by drug plans as a treatment for adults with chronic hepatitis C genotype 1b and with Daklinza, pegylated interferon, and ribavirin, for patients with hep C genotype 1 or 4, if the following criteria/conditions are met:
Recommended Clinical Criteria
- None listed. This is the first CDEC report for a hep C treatment to not recommend that the treatment only be covered for patients who have a liver fibrosis stage of F2 or higher–this is a great omission.
- Drug plans should save money when comparing this treatment’s cost to the cheapest hep C treatment alternative.
Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C.
Reasons for the Above Sunvepra Recommendations
A review of clinical trial results suggests that Sunvepra’s treatment response rates are comparable to success/cure rates of other interferon-free hep C treatments. However, it was noted that there are no trial results with direct comparisons to other treatments already covered by public drug programs. This has also been noted in CDEC recommendations for other hep C treatments.
“There is uncertainty regarding the cost-effectiveness of ASV [Sunvepra] combination regimens…” when they are compared with other hepatitis C treatments.(CDEC)
Noted Discussion Points
- Efficacy of these Sunvepra-based treatment combinations for patients with decompensated liver disease, hepatitis B, or HIV coinfection, malignancy, or recent drug use, remains uncertain. However, the current data indicates that Daklinza + Sunvepra is effective and safe for all of these patients.
- The CDEC believes that there will be “limited use” of pegylated interferon with ribavirin-based treatments when there are interferon-free treatments available.
Further research into patients infected with hepatitis C with L31 or Y93 HCV NS5A-resistant variant at baseline is needed. (CDEC)
Sunvepra (asunaprevir) is prescribed with other hepatitis C treatments/direct-acting antivirals (DAAs). It is a treatment for patients with chronic hepatitis C genotype 1 or 4.
Sunvepra, in combination with Daklinza, peginterferon, and ribavirin, has been tested on those with hep C genotype 1 or 4 who were non-responders (patients who tried treatment but it failed to achieve SVR/a cure) with great results. The cure rate when treating patients with hep C genotype 1 is 93.2%. The cure rate when treating patients with hep C genotype 4 is 100%. (Health Canada)
Lastly, doctors are able to prescribe Sunvepra to patients, but the hepatitis C treatment isn’t covered by PharmaCare yet.