Gilead Receives Health Canada Approval for VOSEVI™, the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment

Please note:  VOSEVI is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans).  VOSEVI is included in Gilead’s Momentum Patient Support Program (information, including contact information, is available below 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.  VOSEVI is at Step 3 and will be progressing through the approval process.  That takes time.  VOSEVI will be added to the pipeline diagram the week of August 21 2017.  Please check back.

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Gilead Receives Approval in Canada for VOSEVI™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-treatment of Certain Patients with Chronic Hepatitis C Virus (HCV) Infection

VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments

MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ – Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor.  The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

“HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients.  However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option,” said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta.  “VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients.”

VOSEVI is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV infection, with the convenience associated with once-daily single-tablet regimens.  Since 2013, Gilead has brought to market four HCV treatments, including three single-tablet regimens. To date, more than an estimated 1.5 million patients worldwide have been prescribed sofosbuvir-based regimens.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said Kennet Brysting, General Manager, Gilead Canada. “The approval of VOSEVI in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030.”

The approval of VOSEVI is supported by Phase 3 data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 infection with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as Phase 3 data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3 or 4 infection with or without compensated cirrhosis who had failed prior treatment with a DAA-containing regimen that did not include an NS5A inhibitor.  In these populations across the two studies, 431 of the 445 patients treated with VOSEVI (97%) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (≥10 per cent of patients) among patients who received VOSEVI were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2 per cent for subjects who received VOSEVI for 12 weeks.

“As Canada moves forward with its World Health Organization commitment to eliminate hepatitis C by 2030, it is important for all patients to have the opportunity to access a cure, regardless if they are new to treatment, or they have failed a previous therapy,” said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital.  “Treatment should be an option for everyone, including to those still seeking a cure.  The CLF is pleased to see that additional effective therapies are available, and are becoming more accessible to all patients, regardless of where someone lives, or their ability to pay.”

Patient Support Program
To assist eligible HCV patients in Canada with access to VOSEVI, Gilead Canada has added VOSEVI to the Gilead Momentum Support Program™, which provides information to patients and healthcare providers to help facilitate patient access to medication.  For more information regarding the Momentum Support Program in Canada, please call 1-855-447-7977.

Important Safety Information
The VOSEVI Product Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX REGARDING THE RISKS OF HEPATITIS B VIRUS (HBV) REACTIVATION IN HCV/HBV CO-INFECTED PATIENTS.  For further details, please see the Canadian Product Monograph at www.gilead.ca.

Contraindications
VOSEVI is contraindicated with the following drugs products: dabigatran etexilate, phenobarbital, phenytoin, rifampin, rosuvastatin.  VOSEVI is also contraindicated with the herbal product, St. John’s wort.

Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with VOSEVI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Drug Interactions
Coadministration of VOSEVI is not recommended with carbamazepine, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, efavirenz, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir and/or voxilaprevir, and/or the other agent.

For additional important safety information for VOSEVI, including the complete warnings and precautions, adverse reactions and drug-drug interactions, please see the Canadian Product Monograph at www.gilead.ca.

About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases.  Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.  Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2006.

Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing VOSEVI for the treatment of adults with chronic HCV infection. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Canadian Product Monograph for VOSEVI, including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.gilead.ca.

VOSEVI is a trademark of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

SOURCE Gilead Sciences, Inc.

 

 

 

 

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.

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  • 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

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National screening guidelines for hep C abandon baby boomers.

Once again, the largest group of people at risk for living with hepatitis C in Canada  – baby boomers – are excluded from the Canadian Task Force on Preventive Health (CTFPH)’s hepatitis C screening guideline recommendations.

As a community-based, lived experience organization, we urge testing of all at-risk groups, including those born between 1945 – 1965 in BC. Two-thirds – some 55,000 people call in that group in here in BC.

We also urge the new British Columbia Minister of Health, when that person is appointed, to consider the extensive data in British Columbia that supports identifying all those in the age cohort of 1945 – 1965 and linking them with care and treatment for better health and budget outcomes.

“If not” says Pacific Hepatitis C Network (PHCN) President Daryl Luster, “and provinces and territories endorse these new guidelines as practice, physicians and public health practitioners will end up doing great harm.”

To abide by the CTFPH’s poorly reasoned guidelines means some people in British Columbia will remain undiagnosed and are or will become sick with liver disease. They may get too sick for treatment. They’re at-risk for premature death and for other chronic diseases like diabetes and heart disease.

PHCN’s Daryl Luster has first-hand experience. “As a person who is part of the baby boomer age group who was diagnosed only by accident, with symptoms for years, the assertion that asymptomatic people will only be harmed by a positive diagnosis is crazy-making.”

And stunningly wrong. It is widely known in the research that people living with HCV can have NO symptoms until they have such advanced disease  that they may not be able to take treatment, may end up with liver cancer and may suffer premature death. We also now know that treating before liver disease sets in yields better health outcomes overall. However, even if treatment isn’t an option, how ethical is it to keep critical information about a person’s health from them? That isn’t a decision for those in the health care system to make alone.

“I am one of the lucky ones” Daryl points out. “I was able to get into a clinical trial – 1 year long – and I was cured. But I still have health issues in part because it took so long to get a diagnosis.”

Another key CTFPH argument against screening the 1945 – 1975 (nationally) age cohort in Canada is that,

“…there are some people in Canada who don’t know they have the virus and if we did screen them and treat them, the cost of treatment would be very high, based on the super-high drug costs.” 

“The comments about price of treating people,” says Daryl Luster, “are once again an insult to me and all of us who are aware that prices in Canada are now substantially lower due to recent negotiations. The cost of ignoring a significant number of people living with hepatitis C will be substantial over time, putting a greater burden on health budgets across Canada, not less. “

In fact, finding and treating people living with hepatitis C saves lives and money. These cost savings were true even before the recently announced new drug pricing for hepatitis C treatments. Now, significantly lower drug pricing, which the CTFPH failed to take into consideration, leaves their argument at best based on inaccurate, out-dated information.

The fight isn’t over yet. This exclusion is not acceptable in the community of those living with and working hard to reach and cure all those living with hepatitis C. We are nearly unanimously united in our outcry against this recommendation and for the inclusion of age-based screening in the national hep C screening recommendations.

In the meantime, if you were born between 1945 and 1975, get tested for hep C. If you test positive, find out if you still have the virus. That’s a second test.  And stay in touch with us.

For more responses to the screening recommendations released this week:

Canadian Liver Foundation

Dr Eric Yoshida

For more in-depth reading about the CTFPHC’s guidelines:

Hepatitis C (2017)

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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.

 

The PHCN’s News in Review Newsletter (06/04/17)

The PHCN's News in Review Newsletter (07/04/17)Welcome to the Pacific Hepatitis C Network (PHCN)‘s Hepatitis C News in Review Newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to a blog post about the importance of eliminating hepatitis C.

Hepatitis C Elimination is Possible and Essential

The group most impacted by hepatitis C, some 60,000 in B.C., are baby boomers, those who were born between 1945 and 1965. Many have lived with the infection for years but have never been tested or treated because they have never believed themselves to be at risk.  This is the time that everyone, including baby boomers, should be tested and treated for hepatitis C.

Relapse, Recurrence, Null & Partial Response/rs

In hepatitis C and hep C treatment there are three ‘R’s that are big, sad, and scary. They are the bringers of sadness that if doctors, friends, and communities could protect someone from, they would. Click the above link for more information.

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Coverage for four hepatitis C treatments has changed. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being or have been added to various provincial formularies across Canada.

Technivie and BC PharmaCare

Technivie, 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.

Holkira Pak and BC PharmaCare

The 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 wont cover it.

Blog Posts by PHCN’s President Daryl Luster

Coming this Spring

Eh, starting this spring, Help-4-Hep helpline will be in Canada.  Help-4-Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Look for more details to come or call the American Help-4-Hep helpline all free of charge.

For more information about hepatitis C and its cures, please email or visit the Hepatitis C Treatment Information Project.

Hepatitis C Elimination is Possible and Essential

Hepatitis C Eliminate is Possible and EssentialTwelve years ago a neonatal nurse adopted Kagen, a blonde haired blue-eyed baby boy. He’s now tall, sports a buzz cut, and likes playing Pokemon Go and visiting Build-A-Bear.

With the desire to help people in rural Appalachia, Naomi became a registered nurse and had dreams of one day becoming a doctor. While working in the fast paced ICUs in Nashville, Naomi remembers often being stuck by needles and being covered in bodily fluids while helping patients.

As a boy, Abdel remembers lining up once a month with his classmates for injections against schistosomiasis, a parasitic disease spread by water snails in Egypt, where he lived. As he was afraid of needles, he always tried his best to be last in line and never wondered where the needle had been before it poked him.

Forty years ago, Julia gave birth to her first child, a daughter. After her daughter’s birth, Julia haemorrhaged and was saved by a blood transfusion.

Each one of the above people have families, hopes, dreams, plans to live until they are old and gray — we all do — and they probably still hold on to those dreams. However, until recently, those dreams may have seemed out of reach for them because of something else they also had in common. All four of them, Kagen, Naomi, Abdel, and Julia, had hepatitis C, a virus that easily passes through blood.

Hepatitis C is a serious and potentially life-threatening liver disease that can lead to liver cirrhosis, cancer, or liver failure. However, in many cases those life-threatening developments may only develop after years of having no symptoms at all or having hepatitis C symptoms that can be written off as symptoms of the normal process of aging.

The group most impacted by hepatitis C, some 60,000 in B.C., are baby boomers, those who were born between 1945 and 1965. Many have lived with the infection for years but have never been tested or treated because they have never believed themselves to be at risk. Having the virus has just never crossed their minds as hep C symptoms can often take decades to emerge and when they do can just seem to be normal signs of aging.

Thankfully, testing for the virus is quick, easy, and can be done confidentially and at home. Thankfully, there are now new pills able to cure it.

With these services and treatments, British Columbia now has the opportunity to achieve a huge public healthcare feat. B.C. can avoid the cost of increased rates of liver cancer, end stage liver disease, and the consequences of hepatitis C’s symptoms, just by seeking out those carrying the hepatitis C virus and treating them.

However, as the virus can quickly and quietly spread, identifying those with the virus in B.C. and treating everyone infected, in a relatively short period of time, is the best way to eliminate it. In 2015, Prince Edward Island, for example, as well as other areas around the world, adopted this strategy and proved that hepatitis C elimination is possible. They proved that eliminating the hepatitis C virus should now be the world’s only course of action against the virus and that British Columbia should adopt a strategy of elimination as soon as possible.

For more information about hepatitis C and its cures, please visit the Hepatitis C Treatment Information Project.


Sources:
CBC News. $5M hepatitis C strategy announced by P.E.I. government. Feb 12, 2015. http://www.cbc.ca/news/canada/prince-edward-island/5m-hepatitis-c-strategy-announced-by-p-e-i-government-1.2954701 Accessed on Mar. 2017.
Everyday Health. Singer Naomi Judd Raises Her Voice on Hepatitis C. July 2014, http://www.everydayhealth.com/columns/my-health-story/singer-naomi-judd-raises-her-voice-hepatitis-c/. Accessed Mar. 2017.
“Generation Hep”. Generationhep.com. Accessed Mar. 2017.
McNeil, Donald. “Curing Hepatitis C, In An Experiment The Size Of Egypt”. Nytimes.com, 2015, https://www.nytimes.com/2015/12/16/health/hepatitis-c-treatment-egypt.html?_r=0 Accessed on Mar. 2017.
Southeast Missourian. Thankful people: Kagen Hill cured of hepatitis C, 2016, http://www.semissourian.com/story/2363041.html. Accessed Mar. 2017.

Relapse, Recurrence, Null & Partial Response/rs: The Basics

Relapse, Recurrence, Null & Partial Response/rs: The BasicsIn hepatitis C and hep C treatment there are three ‘R’s that are big, sad, and scary. They are the bringers of sadness that if doctors, friends, and communities could protect someone from, they would.

The Three ‘R’s of Hepatitis C Treatment

Recurrence
When treatment has been successful but over time the person has been infected with the hepatitis C virus again.

Relapse
When treatment has been successful but over time the virus has come back.

Null/Non Response/rs & Partial Response/rs
A null response is when treatment doesn’t work to suppress the virus. The viral count of hep C in one’s blood doesn’t decrease. Those with a partial response saw the hep C decrease at week 12 but undesirably high levels of virus in the blood at week 24. Both types of patients went through unsuccessful hep C treatments.

Peer Supports, Support Groups, and Online Forums

Whether hep C patients and/or their supports are facing recurrence, relapse, or non-response, there are a number of support groups and hotlines available to support you and to answer your questions. Also, going online is a great way to find local groups and connect to communities through social media, especially on Facebook.

Additional Information

Small Sampling of Journal Articles and Abstracts
Blog Posts

However, something to note is that this blog post was written a couple of months ago and since then, new and better treatments have become available and are covered by BC PharmaCare.

 

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded CoverageCoverage for four hepatitis C treatments is changing. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being added to provincial formularies across Canada.

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.

For more information about what treatment is covered in your province, we have created an easy to understand webpage with links to more information.

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. The links within the table will take you to information about the treatments and to information about treatment coverage.

Lastly, towards the bottom of the webpage, there are links to information about Canadian clinics and additional resources about hepatitis C treatment coverage outside of BC.

However, please note that one of the most important things to know when looking into hepatitis C and its treatment, far beyond what treatments are covered by your province now, is that being in contact with a healthcare practitioner, who is regularly monitoring your health, is essential.

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