| 524 | For 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, 2, 3, 4, 5, 6 or mixed genotypes; 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 for Vosevi (sofosbuvir-velpatasvir-voxilaprevir):
Treatment-experienced, non-cirrhotic or compensated cirrhosis (2)
Approved duration: 12 weeks
Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of Vosevi will be considered on a case-by-case basis through the Exceptional Access Program. |
| | LU Authorization Period: 12 Weeks. |
| | NOTE: 1. Treatment-experienced are those who failed prior therapy with a HCV regimen containing:
i. NS5A inhibitor* for genotype 1, 2, 3, 4, 5, or 6; OR
ii. Sofosbuvir (Sovaldi) without an NS5A inhibitor for genotype 1, 2, 3, or 4
*NS5A inhibitors include: daclatasvir (Daklinza), elbasvir (as part of Zepatier), ledipasvir (as part of Harvoni), ombitasvir (as part of Holkira Pak), velpatasvir (as part of Epclusa), pibrentasvir (as part of Maviret)
2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Scores 5 to 6]) 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. |
