Comparing Hep C Treatments

Comparing Hep C TreatmentsTables Comparing the Hep C Treatments that are Covered by BC’s PharmaCare

PharmaCare Covered Hep C Treatments for Genotype 1 – 6 or Mixed Genotype Infections

Epclusa (sofosbuvir/velpatasvir)
Drug Class Nucleotide NS5B Polymerase Inhibitor
Targeted Genotypes (GT) 1 – 6
Approximate SVR (Approx Rate of “Cure”) 93% – 99%
PR Required** No
Daily Pills 1
Weeks of Treatment 12
Possible Side Effects (Taking treatment with ribavirin can increase the type, frequency, and intensity of side effects)
  • Fatigue (Tiredness)
  • Anemia
  • Nausea
  • Headache
  • Insomnia (Can’t sleep)
  • Diarrhea
Drug Warnings (Please see online product monographs for more information.) Patients with Bradycardia taking amiodarone can not take Epclusa. There have been reports of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart). Don’t take rifampin, St. John’s wort, or carbamazepine while taking Epclusa.

If you have ever had hepatitis B, the hepatitis B virus could become active again during and after taking Epclusa.

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 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
  • A liver fibrosis stage F2 or greater OR less than F2 with the following:
    • Co-infection with HIV or hepatitis B virus
    • Post organ transplant (liver and/or non-liver organ transplant)
    • Extra-hepatic manifestations5
    • Chronic kidney disease stage 3, 4 or 5 as defined by National Kidney Foundation Kidney Disease outcomes Quality Initiative6
    • Co-existent liver disease with diagnosis evidence for fatty liver disease (e.g., non-alcoholic steatohepatitis)7
    • Diabetes receiving treatment with anti-diabetic drugs
    • Women who are planning pregnancy within the next 12 months
Patient Assistance Program Contact Information Gilead’s 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. Zepatier also treats hep C genotype 1. See information just below.

PharmaCare Covered Hep C Treatments for Genotype 1 a/b

Galexos (simeprevir) with Pegylated Interferon with Ribavirin (PR) Harvoni (ledipasvir and sofosbuvir) Sovaldi (sofosbuvir) with Ribavirin Sunvepra (Asunaprevir)
Drug Class NS3/4A Protease Inhibitor NS5A Inhibitor and Nucleotide NS5B Polymerase Inhibitor Nucleotide NS5B Polymerase Inhibitor NS3/4A protease inhibitor
Targeted Genotypes (GT) 1a/b without Q80K variant 1a/b 1a/b 1b
Approximate SVR (Approx Rate of “Cure”) 77 – 87% 93 – 99% 90 – 95% 89 – 100%
PR Required** Yes No Yes No
Daily Pills 3 + weekly pegylated interferon (PI) 1 3 + ribavirin 1 + 1 Daklinza
Weeks of Treatment (Click for Details) 12 + 12 – 36 of PR 8, 12 or 24 12 or 24 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
  • Headache
  • Insomnia
  • Low red blood cell count
  • Nausea
  • Tiredness
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
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
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
Fibrosis stage less than F2 (Metavir scale or equivalent)4 AND at least one of the following:

  • Co-infection with HIV or hepatitis B virus
  • Post organ transplant (liver and/or non-liver organ transplant)
  • Extra-hepatic manifestations5
  • Chronic kidney disease stage 3, 4 or 5 as defined by National Kidney Foundation Kidney Disease outcomes Quality Initiative6
  • Co-existent liver disease with diagnosis evidence for fatty liver disease (e.g., non-alcoholic steatohepatitis)7
  • Diabetes receiving treatment with anti-diabetic drugs
  • Women who are planning pregnancy within the next 12 months
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.
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 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. Zepatier also treats hep C genotype 1. See information just below.

PharmaCare Covered Treatments for Hep C Genotypes 2 – 6

Pegylated Interferon with Ribavirin (PR)* Ribavirin Sovaldi (sofosbuvir) with ribavirin** Daklinza (daclatasvir) Zepatier (elbasvir/ grazoprevir)
Drug Class Nucleoside Analog Nucleotide NS5B Polymerase Inhibitor NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor
Targeted Genotypes (GT) 2 – 6 2, 3 2, 3 3 1, 4
Approximate SVR GT 2: < 80% See Sovadi (sofosbuvir) with ribavirin

The amount of daily pills required depends on one’s weight. Typically, the dose is 1,000 mg/day for persons less than 165 lbs. (75 kg.) and 1,200 mg/day for those 165 lbs. (75 kg.) or greater.

GT 2: 85 – 95% 89% – 100% 90% – 98%
GT 4: < 65%
GT 3, 5, 6: <40% GT 3: 75 – 85%
PR Required This is PR No No No
Daily Pills ribavirin + weekly pegylated interferon (PI) 1 + ribavirin 2 +/- ribavirin 1 +/- ribavirin
Weeks of Treatment
14 or 24 Genotype 2: 12 12 8, 12, 16
Genotype 3: 24
Possible Side Effects (Taking treatment with ribavirin can increase the type, frequency, and intensity of side effects)
  • Can’t Sleep
  • Depression / mood change
  • Diarrhea
  • Dizziness
  • Dry mouth
  • Fatigue / weakness
  • Fever
  • Flulike / Cold like symptoms
  • Hair loss
  • Headache
  • Low platelets (thrombocytopenia)
  • Low white cells (neutropenia)
  • Muscle / joint / back aches
  • Nausea
  • Stomach issues
  • Tiredness
  • Anemia, hemolytic (low red cells)
  • Dizziness / lightheadedness
  • Fatigue
  • Increased heart rate
  • Insomnia
  • Itchy / dry skin
  • Loss of appetite
  • Mood issues (anxiety, depression, irritability, moodiness)
  • Nausea
  • Shortness of breath
  • Taste changes
  • Trouble concentrating
  • Upset stomach (dyspepsia)
  • Weakness
  • Headache
  • Tiredness
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Trouble sleeping
Drug Interactions (Please see online product monographs for more information.) Do not take ribavirin if you are taking didanosine or zidovudine. Tell your doctor if you are taking azathioprine. Ribavirin is a drug that may harm fetuses. Tell your doctor if you may be or may become pregnant. Sovaldi can not be taken by those:

  • With bradycardia
  • Taking amiodarone

It may interact with drugs and herbs that are metabolized in the liver and intestines such as St. John’s wort.

If you have ever had hepatitis B, the hepatitis B virus could become active again during and after taking Daklinza. Tell your doctor if you take any of the following medicines as they may interact with Zepatier:

  • Tracleer: for pulmonary arterial hypertension
  • Alertec: to help people who cannot stay awake
  • Ketoconazole: to treat fungal infections
  • Tacrolimus: to stop organ transplant rejection
  • Elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate: a drug combination to treat HIV
  • Treatments for high cholesterol
BC’s PharmaCare Coverage Requirements Genotype 2: Treatment naive patients who can’t take interferon for medical reasons or have already tried PR
Genotype 3: Patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried PR
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. A liver fibrosis stage F2 or greater OR less than F2 with the conditions listed at this link
Additional PharmaCare Notes Ribavirin and Sovadi (sofosbuvir) do not come together. Re-treatment requests will not be considered. PharmaCare covered for HIV/HCV coinfection if above criteria is met
Patient Assistance Program Contact Information PEGAssist Patient Support Program 1-877-734-2797 Ibavyr Patient Support Program 1-844-602-6858 Gilead’s Momentum Patient Assistance Program 1-855-447-7977 CLAIRE Program 1-844-HCV-2559
Merck Care Program 1-866-872-5773
*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.**Sovaldi (sofosbuvir) and pegylated interferon with ribavirin is approved for use in Canada to treat hep C genotype 4 but isn’t covered by BC’s PharmaCare.

Length of Treatment for Galexos

Patients HCV RNA at Week 4* Galexos + Peginterferon + Ribavirin
Additional Peginterferon + Ribavirin
Total # of Weeks
Haven’t been treated OR have relapsed Undetectable First 12 weeks Additional 12 weeks 24
<25 IU/mL detectable* First 12 weeks Additional 36 weeks 48
Tried treatment but didn’t respond OR only partially responded Undetectable or <25 IU/mL detectable* First 12 weeks Additional 36 weeks 48
*Viral load tests determine how much virus (HCV RNA) is in the blood. If their results are higher than certain amounts, or if there is more virus in the blood than a certain amount, longer or additional treatments may be recommended. The IU/ml mean International Units per milliliter and is used in reporting viral load test results. In this case, for patients with a level of hep C virus of < 25 IU/ml at 4 weeks of treatment, an additional 36 weeks of treatment would be prescribed as shorter durations have higher relapse rates.

Length of Treatment for Harvoni

For the treatment of chronic hepatitis C genotype 1 in: # of Weeks
Patients who haven’t been treated, are without cirrhosis, with viral loads < 6 million IU/mL* 8
Patients who haven’t been treated, are without cirrhosis, with viral load ≥ 6 million IU/mL 12
Patients who haven’t been treated who have or don’t have cirrhosis 12
Patients who have been treated with cirrhosis 24
*Viral load tests determine how much virus (HCV RNA) is in the blood. If the level of it is higher than a certain level, longer or additional treatments may be recommended. IU/ml means International Units per milliliter. It’s used in reporting viral load test results. In this case, for patients with an initial level of hep C virus of ≥ 6 million IU/mL, a 12-week regimen is optimal, as shorter durations have higher relapse rates.

Length of Treatment for Holkira Pak

Genotype Previously Treated Cirrhosis Treatment # of Weeks
1a Yes or No No 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV* 12
1b Yes or No No 2 pills once daily + 1 pill twice daily 12
1a/1b No Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 12
1a Yes Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 24**
*RBV stands for ribavirin. Holkira Pak with ribavirin is recommended for patients with an unknown genotype 1 subtype or with mixed genotype.
**24 weeks of Holkira Pak + ribavirin is recommended for patients with genotype 1a infection with cirrhosis who previously didn’t respond to pegylated interferon and ribavirin (PR).

Length of Treatment for Sovaldi

Treatment Patients # of Weeks
Sovaldi (sofosbuvir) with pegylated interferon and ribavirin (PR) Genotype 1 patients who have never tried treatment 12
Sovaldi (sofosbuvir) with ribavirin Genotype 2 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR)* 12
Genotype 3 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR) 24
*Genotype 2 or 3 patients who have tried treatment are patients who have previously been treated with pegylated interferon with ribavirin but weren’t cured. Similar treatment lengths are also used to treat genotype 2 or 3 HCV patients co-infected with HIV.