Treatments Covered by BC PharmaCare for Hep C Genotypes 1a/1b

Treatments Covered by BC PharmaCare for Hep C Genotypes 1a/1bComparing Treatments Covered by BC PharmaCare for Hep C Genotypes 1a/1b

Galexos (simeprevir) with Pegylated Interferon with Ribavirin (PR) Harvoni (ledipasvir and sofosbuvir) Holkira Pak (ombitasvir / paritaprevir / ritonavir + dasabuvir) Holkira Pak (ombitasvir / paritaprevir / ritonavir + dasabuvir) with Ribavirin Sovaldi (sofosbuvir) with PR
Drug Class NS3/4A Protease Inhibitor NS5A Inhibitor and Nucleotide NS5B Polymerase Inhibitor NS5A Inhibitor / NS3/4A Protease Inhibitor / Non-Nucleoside NS5B Polymerase Inhibitor +/- Nucleoside Analog Nucleotide NS5B Polymerase Inhibitor
Targeted Genotypes (GT) 1a/b without Q80K variant 1a/b 1b 1a 1a/b
Approximate SVR (Approx Rate of “Cure”) 77 – 87% 93 – 99% 90 – 100% 90 – 100% 90 – 95%
PR Required** Yes No No No Yes
Daily Pills 3 + weekly pegylated interferon (PI) 1 4 4 + ribavirin pills 3 + weekly pegylated interferon (PI)
Weeks of Treatment (Click for Details) 12 + 12 to 36 of PR 8, 12 or 24 12 24 12 or 24
Possible Side Effects (Taking treatment with ribavirin can increase the type, frequency, and intensity of side effects)
  • Constipation
  • Increased bilirubin levels in one’s blood
  • Sensitivity to sunlight
  • Skin rash

Plus side effects from PR

  • Diarrhea
  • Insomnia
  • Headache
  • Nausea
  • Tiredness
  • Diarrhea
  • Headache
  • Insomnia
  • Itchiness
  • Nausea
  • Tiredness
  • Diarrhea
  • Headache
  • Insomnia
  • Itchiness
  • Nausea
  • Tiredness

Plus side effects from ribavirin

 

  • Headache
  • Insomnia
  • Low red blood cell count
  • Nausea
  • Tiredness

Plus side effects from PR

Drug Warnings (Please see online product monographs for more information.) Galexos should not be taken by those with moderate to severe liver impairment (Child-Pughs B and C). Harvoni can not be taken by those:

  • With bradycardia
  • Taking amiodarone
Holkira Pak should not be taken by those with moderate to severe liver impairment (Child-Pughs B and C).

Holkira Pak should not be taken with the following:

  • Ethinyl estradiol-containing medicines (such as some birth control products);
  • Drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations are associated with serious adverse reactions;
  • Strong CYP2C8 inhibitors and inducers;
  • Moderate or strong inducers of CYP3A
Sovaldi can not be taken by those:

  • With bradycardia
  • Taking amiodarone
General Hep C Treatment Usage Warning Do not take treatments while taking recreational drugs or over-the-counter drugs, such as St. John’s wort, without first talking with your healthcare provider as they may interact with each other. Tell your doctor if you may be or may become pregnant. The safety and efficacy of most of these treatments in children less than 18 years of age has not been established.
BC’s PharmaCare Coverage Requirements (All of the following requirements DO NOT have to be met.)

OR

  • Treatment naive patients with or without cirrhosis

OR

  • Treatment experienced patients with or without cirrhosis

 

  • Treatment naive patients with or without cirrhosis

OR

  • Treatment experienced patients with or without cirrhosis
  • Treatment naive or experienced patients with or without cirrhosis

OR

  • Treatment experienced with cirrhosis and who have relapsed or had a partial response to PR

OR

  • Treatment experienced with cirrhosis and who have had a previous null response to PR
  • Treatment naive patients with or without cirrhosis
BC’s PharmaCare Coverage Requirements (All of the following requirements MUST be met.)
  • Lab-confirmed hepatitis C and the right genotypes for the treatment. If a patient has genotype 1 but had their genotype subtype diagnosis prior to May 1, 2012, they require a new genotyping test. HCV genotyping must be repeated for treatment-experienced patients.
  • Detectable levels of hep C in the last 6 months
  • A liver fibrosis stage F2 or greater
  • A Special Authority request completed by a specialist or physician experienced with treating hep C
  • NOT currently treated with another hep C treatment/hep C antiviral agent
Additional Treatment Specific Requirements for BC’s PharmaCare Coverage Doesn’t treat hep C genotype 1a with Q80K variant. The following patients are not eligible for coverage:

  • Patients previously treated with a NS3/4A protease inhibitor
  • Patient currently being treated with NS5A/NS5B inhibitor
See Length of Treatment table for more information. The following patients are not eligible for coverage:

  • Patients who have received previous NS3/4A protease inhibitors
  • Patients who have received previous sofosbuvir-based regimens including Harvoni
Special PharmaCare Notes In exceptional cases, requests that do not meet the criteria above may receive special consideration for coverage if the physician provides additional documentation of disease progression and/or for other patient-specific considerations. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews exceptional case submissions.
Additional PharmaCare Notes Preferred options over pegylated interferon-based treatments. PharmaCare covered for HIV/HCV coinfection if above criteria is met. PharmaCare covered for HIV/HCV coinfection if above criteria is met
Patient Assistance Program Contact Information Galexos: Bioadvance Program 1-855-512- 3740 Momentum Patient Assistance Program 1-855-447- 7977 AbbVie Care 1-844-471-2273 Momentum Patient Assistance Program 1-855-447- 7977
*PR stands for pegylated interferon with ribavirin. It may be combined with other drugs for the treatment of hep C genotype 1 or it may be prescribed alone for hep C genotypes 2 – 6.

Further Treatment Links and Resources

Hepatitis C Treatment OPTIONS: Basic Information for Patients by Hepatitis Education Canada
This interactive tool will provide you with personal hepatitis C treatment recommendations that can be printed for reference or to taken your provider. (Canadian)

Comparing Treatments Covered by BC PharmaCare for Hep C Genotype 1a/b