Sovaldi

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.

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.