| 482 | 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 1; 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).
Treatment regimens:
- Treatment-naive, non-cirrhotic, recent quantitative hepatitis C viral load less than 6 M IU/mL
Approved duration: 8 weeks
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: 8 Weeks |
| 483 | 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 1; 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).
Treatment regimens:
I. Treatment-naive, without cirrhosis, viral load greater than or equal to 6 M IU/mL; or treatment-naive with cirrhosis; or treatment-experienced without cirrhosis
Approved duration: 12 weeks
II. Treatment-naive or treatment-experienced with decompensated cirrhosis (2)
Approved regimen: 12 weeks in combination with ribavirin (Ibavyr)
III. Treatment-naive or treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (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. |
| 484 | 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 1; 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).
Treatment regimen:
- Treatment-experienced, cirrhotic:
Approved duration: 24 weeks
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. Scores 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered.
3. 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. |
