| 485 | In combination with ribavirin (Ibavyr) for treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria:
(i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND
(ii) Laboratory confirmed hepatitis C genotype 2; AND
(iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart;
OR
One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use).
For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) as the preferred therapeutic option over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections.
Treatment regimens for sofosbuvir (Sovaldi) for genotype 2:
- Treatment-naive or treatment-experienced genotype 2
Approved regimen: 12 weeks in combination with ribavirin (Ibavyr)
Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program. |
| | LU Authorization Period: 12 Weeks. |
| 487 | In combination with ribavirin (Ibavyr) for treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria:
(i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND
(ii) Laboratory confirmed hepatitis C genotype 3; AND
(iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart;
OR
One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use).
For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) as the preferred therapeutic option over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections.
Treatment regimens for sofosbuvir (Sovaldi) for genotype 3:
- Treatment-naive or treatment-experienced without cirrhosis, or with compensated cirrhosis (2), or with decompensated cirrhosis (2), or post-liver transplant
Approved regimen: 24 weeks in combination with ribavirin (Ibavyr).
Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program. |
| | LU Authorization Period: 24 Weeks. |
| | NOTE: 1. Treatment-experienced are those who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Score 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered.
3. Combination therapy with Zepatier (elbasvir/grazoprevir) will not be considered for funding.
4. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. |
