Tag Archives: BC PharmaCare

AbbVie’s MAVIRET™ Approved by Health Canada for the Treatment of Chronic Hepatitis C in All Major Genotypes

Please note:  MAVIRET is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans).  MAVIRET is included in AbbVie’s patient support program, AbbVie Care. Information, including contact information, is available here and here.

See the Hep C Treatment Diagram on the left hand side of this page (homepage has 2 versions) for a picture of Canada’s drug approval system and where hep C treatments are at in it.  MAVIRET is at Step 3 and will be progressing through the approval process.  That takes time.  MAVIRET (glecaprevir/pibrentasvir) information will be updated on the pipeline diagram the week of August 21 2017.  Please check back.

________________________________________________________________________

  • MAVIRET is the first and only 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment*1
  • The approval is supported by a 97 percent (n=639/657) cure** rate across GT1-6 patients without cirrhosis and who are new to treatment2
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, Aug. 17, 2017 /CNW/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that Health Canada has granted approval for MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who make up a large portion of HCV patients in Canada.

“Despite recent advances in HCV treatment, physicians still face challenges treating patients with less common genotypes and those with other complicating health conditions,” said Dr. Morris Sherman, MD, FRCPC, Chairperson, Canadian Liver Foundation. “In order to eliminate hepatitis C in Canada, we need to identify all those living with the virus and have effective treatment options for everyone. This new therapy provides another tool for physicians to expand treatment to a greater number of patients while at the same time shortening the duration which may lead to cost savings for the health care system.”

MAVIRET is also approved for use in patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD), those GT1 patients not previously cured with certain direct-acting antiviral (DAA) treatment, and those with GT3 chronic HCV infection.2 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.2

“With the approval of MAVIRET, we are proud to bring the hope of a new cure to people living with hepatitis C in Canada, reflecting AbbVie’s dedication to addressing critical unmet needs for patients,” said Stéphane Lassignardie, General Manager, AbbVie Canada. “MAVIRET is designed to deliver a virologic cure for most HCV patients including those with specific treatment challenges. AbbVie will continue to work with local health authorities and stakeholders across Canada to get our treatment to as many patients as possible.”

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

Approximately 300,000 Canadians are infected with hepatitis C.3 In 2012 alone, more than 10,000 new cases of hepatitis C were reported, but 40 percent of patients are estimated to be living unaware of their disease.4 GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.3,5 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years6 of infection. Additionally, HCV is common among people with severe CKD, and some of these patients previously did not have a DAA-based treatment option.7

With 8 weeks of treatment, 97 percent (n= 639/657) of GT1-6 patients without cirrhosis and who were new to treatment achieved a virologic cure.1 These high cure rates were achieved in patients with varied patient and viral characteristics and including those with CKD.2 Additionally, 97.5 percent (n=274/281) of patients with compensated cirrhosis achieved a virologic cure with the recommended duration of treatment, including patients with CKD.2 In registrational studies for MAVIRET, less than 0.1 percent of patients permanently discontinued treatment due to adverse reactions.2 The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.2

“In an extensive clinical trial program, patients achieved high cure rates with MAVIRET regardless of genotype, fibrosis score, viral load, and even in patients with resistant virus strains and those with chronic kidney disease,” said Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist, Director of the Toronto Liver Centre. “In clinical practice, MAVIRET has the potential to simplify treatment decisions for physicians, offering, in one therapy, a cure for the majority of HCV patients and cutting out pre-testing before treatment initiation.”

MAVIRET combines two new, potent direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus.2 The presence of most genotypes or baseline mutations that are commonly associated with resistance have been shown to have no relevant impact on efficacy.2

Canadians prescribed MAVIRET will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature patient support program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support. AbbVie Care will support people living with HCV throughout their treatment journey to achieve high cure rates in the real world.

Approval of MAVIRET followed Health Canada’s Priority Review process, which is granted to new medicines intended for patients with a life-threatening disease where there is no existing treatment with the same profile or where the new product represents a significant improvement in the benefit/risk profile over existing products.8 AbbVie’s investigational, pan-genotypic regimen was also recently approved by the European Commission and the U.S. Food and Drug Administration.

About MAVIRET™
MAVIRET™ is approved in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).2 MAVIRET is a new, pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.2

MAVIRET is an 8-week, pan-genotypic virologic cure** for use in patients without cirrhosis and who are new to treatment,*  such patients comprising the majority of people living with HCV.1 MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) and those with genotype 3 infection.2 It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.2

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. 

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience.  In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.
2 MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017.
3 Messina, JP et al. “The global distribution of HCV genotypes.” Hepatology, 2015; 61: 77–87. Supporting information hep27259-sup-0001-suppinfo.pdf. Accessed August, 2017.
4 Hepatitis C: Get the Facts. Government of Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/poster-hepatitis-c-get-facts.html. Accessed August, 2017.
5 Wyles, D et al. SURVEYOR-II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis. Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, US on November 11-15, 2016.
6 Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed August, 2017.
7 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
8 Priority Review of Drug Submissions. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/priority-review-drug-submissions-therapeutic-products.html. Accessed August, 2017.

SOURCE AbbVie Canada

For further information: Media: Muriel Haraoui, AbbVie Canada, (514) 717-3764, muriel.haraoui@abbvie.com

Save

Candidate Questionnaire – 2017 Provincial Election

All candidates running for office in this 2017 provincial election have been sent this questionnaire and background information.  Results from candidates and parties will be posted in blogs leading up to the election.  

Our question:  Do you support PHCN’s 5 Point Plan to help eliminate hepatitis C from BC by 2030?

Feel free to check in with your candidates in your riding about our question.  Find your candidates here:  http://elections.bc.ca/2017-general-election/candidates/

Feel free to email us at BCElection2017@pacifichepc.org 🙂

Pacific Hep C Network

BC Election 2017 Candidate Questionnaire

New hepatitis C medications are true game-changers. Most treatment courses now take less than three months with minimal side effects and cure rates close to 100 per cent. BC and other provincial governments recently announced a deal with drug manufacturers to get even better value for taxpayers. With the right plan we can eliminate hepatitis C from BC within a generation.

The hepatitis C virus can cause damage for decades with few or no symptoms and can lead to liver cancer and irreversible liver failure. It is one of the five major causes of infectious-illness death globally along with HIV, hepatitis B malaria, and TB.

The group most impacted — some 60,000 people in BC — are those born between 1945 to 1964 (the older adult age cohort). Many have lived with the infection for years but have not gone for testing because neither they –nor their doctors – believe they are at risk.

While a hepatitis C-free future is possible a significant challenge remains: identifying those living with the virus that have not been diagnosed, assessed or treated for their hep C infection. British Columbia needs to refresh its hepatitis C strategy, reinforce health system readiness and expand awareness to motivate high-risk populations to get tested.

We are proposing a five-point action plan to help eliminate hepatitis C from BC by 2030:

  1. Refresh BC Hepatitis C Strategy: Work with stakeholders, including citizens impacted by hepatitis C, to refresh and fund a phased plan with defined timelines.
  2. Update Testing Guidelines: To include older adult screening and/or normalized hepatitis C screening for the general population.
  3. More Continuum of Care Resources: Increase capacity (system and individual health care provider) to test, diagnose, assess, monitor, treat and follow up all people living with hepatitis C in BC.
  4. Expanded Awareness: Implement strategies to motivate at-risk populations (age cohort, immigrants, Indigenous people, injection drug users) to seek screening and care for hepatitis C
  5. Decrease Stigma: Address stigma and discrimination towards those living with and at-risk for hepatitis C within the health care system (i.e. hepatitis C education; cultural competence training requirements).

As you seek elected office we want to know if you support our objectives.

Question: Do you support PHCN’s 5 Point Plan to help eliminate hepatitis C from BC by 2030?

Yes                                                 No

Our vision is for a British Columbia free from new hepatitis C infections with the best possible care and treatment for those living with the virus.

 

Technivie and BC PharmaCare

Technivie and BC PharmaCareTechnivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Technivie is still an approved hepatitis C genotype 4 treatment in Canada. For more information about this, please contact the AbbVie Care program at: 1-844-471-2273.

Technivie (Ombitasvir / Paritaprevir / Ritonavir)

Technivie Background: Hepatitis C genotype 4 only accounts for about 13% of global hep C infections and isn’t as common in Canada as it is in the Middle East and Africa. However, due to increased travel and immigration, the population who have hep C genotype 4 and who live in high-income countries  is growing.

Targeted HCV Genotype:  4

Targeted Patients: Those without liver problems, or with Child-Pughs A, who have never tried hep C treatment or have previously tried peginterferon and ribavirin but weren’t cured by it.

Generic Name:  Ombitasvir / paritaprevir / ritonavir

Treatment Description:  Technivie is made up of 2 direct acting antivirals (ombitasvir and paritaprevir) and ritonavir, a booster for paritaprevir. It is taken without interferon.

Approximate Sustained Viral Response / Cure Rate:  100% with ribavirin, 91% without ribavirin

Daily Dose:  2 pills taken once in the morning with food + ribavirin taken once in the morning and once at night

Length of Treatment:  12 weeks

Thank you to all of those who wrote in for Technivie’s patient input reports that were sent to CADTH and BC PharmaCare. Thank you also to those who worked to develop Technivie, a treatment for hepatitis C genotype 4. Thank you for working in hopes of a better tomorrow for those with hepatitis C genotype 4.

Holkira Pak and BC PharmaCare

Holkira Pak and BC PharmaCareThe hepatitis C treatment Holkira Pak was approved for use in Canada in March 2015 and then was later approved for BC PharmaCare coverage in July  2015. Although Holkira Pak is still approved for use in Canada and has an amazingly high cure rate, as of March 23, 2017, BC PharmaCare has decided not to approve new requests for coverage.

For patients whose coverage was approved before March 23, 2017, BC PharmaCare will continue coverage until their current Special Authority expires. For more information about this change, please contact your doctor, nurse, or call the AbbVie Care program at: 1-844-471-2273.

From all of the BC residents who were able to access Holkira Pak and, therefore, may have been cured of the hepatitis C virus, we would like to thank all of the people who work within the hepatitis C approval pipeline who made their recovery possible.

Holkira Pak

Treatment Description: Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

  • Ombitasvir / Paritaprevir / Ritonavir +/-
  • Ribavirin

Daily Dose: 4 pills +/- ribavirin pills

Sustained Viral Response (SVR)/”Cure Rate”: 95 – 100% with ribavirin

Usage Warning: Holkira Pak should not be taken with/by the following:

  • Those with moderate to severe liver impairment (Child-Pughs B and C);
  • 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;
  • Strong CYP2C8 inhibitors and inducers;
  • Moderate or strong inducers of CYP3A;
  • Recreational drugs.

Length of Treatment:

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).

Common Side Effects Reported in Clinical Trials:

  • Can’t sleep (insomnia)
  • Diarrhea
  • Headache
  • Itchiness
  • Nausea
  • Tiredness

PHCN’s Statement about the Successful Negotiations for 3 New Hepatitis C Treatments

PHCN's Statement about the Successful Negotiations for 3 New Hepatitis C Treatments‘No One Left Behind!’

Pacific Hepatitis C Network (PHCN) is very happy to learn that effective March 21, an extensive list of hepatitis C treatments will be available through BC PharmaCare – at far better prices than they previously had been. The high cost of hepatitis C treatment has effectively restricted the numbers of people living with hepatitis C who could access treatment.

Even with lower prices, those restrictions will remain in place until next year. Come March 2018, those restrictions (requiring a liver fibrosis stage of F2 or greater) will be lifted and hepatitis C treatment will be available to any person living with hepatitis C in BC, “regardless of the type and severity of their disease”.

The Province, via the Ministry of Health, co-led the negotiations for new, affordable prices and we at PHCN are both proud of that fact and sincerely grateful. We hope the same for new, hep C drugs that are currently in development and that improve even more on cure rates, tolerability, length of treatment, and treating more than one HCV genotype.

And with these new developments, our work continues! Now is the time to identify and address the barriers still in place that keep those living with hep C from accessing care and treatment: low levels of primary care provider awareness of hep C and treatments; believes about who deserves treatment and who doesn’t; patient education and outreach to those who were diagnosed years ago but are not engaged in care for their hep C. Stigma can and does underlay many of those barriers and must be addressed.

PHCN applauds the ushering in of the first critical step by BC’s Ministry of Health and we urge continued vigilance and collective planning and action to ensure ’No One Left Behind!’ when it comes to hepatitis C care and treatment in BC.

More information can be found here.

Successful Negotiations for Three New Hepatitis C Treatments

Successful Negotiations for Three New Hepatitis C TreatmentsDirectly copied statement from the pan-Canadian Pharmaceutical Alliance

TORONTO, Feb. 21, 2017 /CNW/ – On behalf of participating federal, provincial and territorial public drug plans, the pan-Canadian Pharmaceutical Alliance (pCPA) has concluded successful negotiations with three drug manufacturers to help jurisdictions expand access to publicly funded medications for the treatment of chronic hepatitis C.

Hepatitis C is a communicable liver disease that is caused by an infection with the hepatitis C virus. Seventy-five per cent of people who have contracted hepatitis C cannot spontaneously clear the virus. This leads to chronic hepatitis C infection. Although many of the estimated 250,000 infected Canadians may have no symptoms for decades, if left untreated, chronic hepatitis C can lead to serious complications such as liver failure and liver cancer.

Just a few years ago, hepatitis C patients took a combination of pills and injections for almost a year and these earlier drugs had lower rates of treatment success. Today’s newer therapies are more effective, available in oral form and require substantially shorter durations of treatment.

These benefits, however, come at a substantial cost. Depending on the drug and disease progression, the list cost for hepatitis C treatments ranged from $45,000 to over $100,000 per patient. Although these costs were made more affordable with previous agreements, the funding of hepatitis C treatments has resulted in significant cost pressures.

Recently, multiple products have become available, creating a more competitive environment for hepatitis C treatment price negotiations.

The pCPA’s approach to hepatitis C treatment negotiations was guided by the following:

  • goal of providing treatment for patients regardless of genotype and disease severity
  • financial affordability and sustainability
  • a fair approach in negotiating value among multiple drugs and manufacturers.

Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada were able to reach an agreement through the pCPA to provide hepatitis C drugs at an improved cost. These agreements will help increase publicly funded access for most patients with hepatitis C.

As with all pCPA drug negotiations, individual participating jurisdictions will be responsible for implementing changes under their respective public drug plans.

SOURCE Pan Canadian Pharmaceutical Alliance (pCPA)

For further information: For more information (media): David Jensen, Ministry of Health and Long-Term Care, 416-314-6197

Our Top 2016 Hepatitis C Treatment Posts as Clicked by You

Our top 2016 hepatitis C treatment posts as clicked by you are as follows:

Our Top 2016 Hepatitis C Treatment Posts as Clicked by YouThe Top 5 Blog Posts Read in 2016

The Top 5 Facebook Posts that Received the Most Reactions/Clicks in 2016

The Subjects of the Top 5 Tweets Posted in 2016

The Top Email Subjects Received by the Hepatitis C Treatment Information Project in 2016

  • I am thinking about starting treatment and am wondering if you can answer the following questions?
  • I am thinking about starting treatment and am wondering about BC PharmaCare’s liver fibrosis stage F2 or greater treatment eligibility cut off.

May 2017 be a year just as full of exciting hep C headlines and developments as 2016 was. Happy New Year from all of us at the Pacific Hepatitis C Network!

Possible Softening of Liver Fibrosis Stage F1> Treatment Requirement

Possible Softening of Liver Fibrosis Stage F1> Treatment RequirementThe Pacific Hepatitis C Network has received reports that at least one Canadian assistance program offered by a pharmaceutical company is working with patients, on a case-by-case basis, to treat those with liver fibrosis stage F1. The status quo, requiring a liver fibrosis stage F2 or higher to access hep C treatment, in Canada may be changing and the Pacific Hepatitis C Network applauds this possible change.

If you have hepatitis C and are interested in treatment, please talk to your healthcare provider about it and keep regular tabs on your liver’s health.

Liver Fibrosis

Liver fibrosis is the early stage of liver scarring. It happens when a liver tries to heal itself and in the process creates scar tissue that can’t do the work of normal liver cells. Fibrosis doesn’t cause symptoms but can lead to portal hypertension or liver cirrhosis. A liver biopsy is used to diagnosis it. Fibrosis can be stopped and some of the changes reversed if the underlying condition is treated.

Liver Fibrosis Stages

There are five stages of liver fibrosis, stage 0 to stage 4 (stage F1-F4). Stage 0 means a liver is normal and doesn’t have fibrosis. Stage 4 is liver cirrhosis. Currently, BC PharmaCare requires a patient to have liver fibrosis stage 2 or higher in order to possibly qualify for hep C treatment coverage. At stage 2, one may still not know that their liver is damaged and may not experience liver failure symptoms such as yellow skin or eyes or abdominal pain.

More information about liver fibrosis and liver cirrhosis can be found in Understanding Cirrhosis of the Liver: First steps for the newly diagnosed, an easy-to-read resource that was put together by CATIE and the Canadian Association of Hepatology Nurses.

Treatments Covered by BC PharmaCare for Hep C Genotypes 2-6

Pan-Genotypic Hepatitis C Treatments: The BasicsPharmaCare 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 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
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 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
  • 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.

Further Treatment Links and Resources about Treatment for Hep C Genotypes 2-6

Treatment Coverage Across Canada
Treatment coverage across Canada is decided upon by each province and territory. This means that not only can treatments vary, and be compared to each other, but treatment coverage may vary from location to location as well. This page is a quick summary of what hepatitis C treatments are covered, in some form or another, by the different provinces and territories across Canada. (Canadian)

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)

PharmaCare Covered Treatments for Hep C Genotypes 2 - 6

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