Comparing Hep C Treatments

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

PharmaCare Covered Hep C Treatments for Genotype 1 a/b

	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 – 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.)	Treatment naive patients with or without cirrhosis OR Treatment experienced patients with or without cirrhosis who are prior relapsers, partial responders, or null responders with or without cirrhosis	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.

PharmaCare Covered Treatments for Hep C Genotypes 2 – 6

	Pegylated Interferon with Ribavirin (PR)*	Ribavirin	Sovaldi (sofosbuvir) with ribavirin**
Drug Class		Nucleoside Analog	Nucleotide NS5B Polymerase Inhibitor
Targeted Genotypes (GT)	2 – 6	2, 3	2, 3
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%
	GT 4: < 65%		GT 2: 85 – 95%
	GT 3, 5, 6: <40%		GT 3: 75 – 85%
PR Required	This is PR		No
Daily Pills	ribavirin + weekly pegylated interferon (PI)		1 + ribavirin
Weeks of Treatment	14 or 24		Genotype 2: 12
Weeks of Treatment	14 or 24		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
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.
BC’s PharmaCare Coverage Requirements	Treatment naive patients with or without cirrhosis		Genotype 2: Treatment naive patients who can’t take interferon for medical reasons or have already tried PR
	Treatment naive patients with or without cirrhosis		Genotype 3: Patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried PR
	Lab-confirmed hepatitis C and the right genotypes for the treatment 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 experienced physician NOT currently treated with another hep C treatment/hep C antiviral agent
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		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
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
Haven’t been treated OR have relapsed	<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
Sovaldi (sofosbuvir) with ribavirin	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.

BPD