Tag Archives: hepatitis c treatment

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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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.

What’s Been Recently Published About Hep C (December/January)

What's Been Recently Published About Hep CThe following highlights a variety of December/January published studies, articles, and press releases about hepatitis C and hepatitis C treatments.

Alimentry Pharmacology & Therapeutis (January 2017)

Summary: This study looked at the effectiveness and predictors of taking pegylated interferon with ribavirin (PR) and patients taking sofosbuvir (SOF) and PR. SVR ranged from 80.9% in the PR group to 96.1% in PR+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90–95% for Daklinza+SOF±RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV based regimens.

Summary: This study looked at the effectiveness and predictors of taking sofosbuvir and ribavirin for 6 months versus taking the treatment sofosbuvir with pegylated interferon with ribavirin for 3 months. Group one achieved a 94% cure rate. In group two 78.7% achieved SVR. These results were similar to those achieved in other clinical trials.

Hepatology (December 2016)

Summary: Combining different DAAs with a variety of mechanisms may help shorten required treatment durations. This study aimed to find the treatment combination promising the best results the fastest. The study gave patients elbasvir/grazoprevir and sofosbuvir for 4-12 weeks. Patients being retreated were given the compound with ribavirin for 12 weeks. Cure rates were as follows:

Patients Treatment Weeks SVR
Without liver cirrhosis hep C genotype 1 4 32%
6 87%
With liver cirrhosis hep C genotype 1 4 80%
6 81%
Without liver cirrhosis hep C genotype 3 6 93%
8 100%
With liver cirrhosis hep C genotype 3 12 83%

The Lancet (December 2016/January 2017)

Summary: This clinical trial looked at the safety and effectiveness of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated anti-miR-122 oligonucleotide. The trial showed that RG-101 could achieve SVR after 4 weeks of treatment.

Recent Press Releases by Pharmaceutical Companies

Patients Treatment Weeks Treatment SVR
GT1 without cirrhosis, some with the resistance-associated Y93H virus variant 8 Glecaprevir / Pibrentasvir 99%
12

Technivie

100%

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.

Health Canada Summary Safety Review – DAAs – Assessing the Potential Risk of Hepatitis B Virus Reactivation

December 1, 2016

Product

Direct-acting antivirals (DAAs)

Potential Safety Issue

Hepatitis B virus (HBV) reactivation

Key Messages

  • Direct-acting antivirals (DAAs) are drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection, a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) and liver cancer.
  • Health Canada carried out a review of the potential risk of hepatitis B virus (HBV) reactivation with the use of DAAs. The review was triggered by reports that patients infected with both HBV and HCV may experience a reactivation of their HBV infection if DAAs are used to treat their HCV infection. These reports were identified by the European Medicines Agency (EMA).
  • Health Canada’s review concluded that there is a potential risk of HBV reactivation in patients co-infected with both HBV and HCV, and the use of DAAs. Health Canada has recommended that the safety information for all DAAs be updated to inform about this potential risk.

Overview

Health Canada carried out this safety review after becoming aware of reports of HBV reactivation in patients infected with both HBV and HCV treated with DAAs. Reactivation refers to the return of an active infection and, in the case of HBV, it can lead to serious complications such as liver disease (hepatitis).

Use in Canada

  • DAAs are prescription drugs authorized for sale in Canada to treat chronic HCV infection in adult patients.
  • This review included the following products available in Canada and they contain either a single DAA or multiple DAAs together: Daklinza (daclatasvir), Sovaldi (sofosbuvir), Harvoni (sofosbuvir, ledipasvir), Epclusa (sofosbuvir, velpatasvir), Holkira Pak (dasabuvir, paritaprevir, ombitasvir, ritonavir), Technivie (paritaprevir, ombitasvir, ritonavir), Galexos (simeprevir), Sunvepra (asunaprevir), and Zepatier (grazoprevir, elbasvir).
  • The first DAA available in Canada was Galexos (simeprevir), introduced in 2013.

Safety Review Findings

  • At the time of the review, Health Canada had not received any Canadian reports of HBV reactivation related to DAA use in patients infected with both HBV and HCV.
  • A total of 13 international reports of HBV reactivation were retrieved from different sources. Of these, 12 reports were considered to be possibly related to the use of these DAAs: 11 reports where sofosbuvir or sofosbuvir with ledipasvir was used and one report where daclatasvir was used. The remaining report (with sofosbuvir use) could not be reviewed further because it did not provide enough information. Of the reports, 3 described symptoms of moderate HBV reactivation. One of the cases reported severe HBV reactivation resulting in liver failure and the patient needed a liver transplant.
  • Potential processes have been proposed in the scientific literature to explain how HBV infection could become reactivated in patients that are being treated for their HCV infection.
  • Two studies of the use of DAAs in patients infected with both HCV and HBV reported an increase in viral genes (HBV DNA) in some of the patients. This could lead to a reactivation of the HBV infection.

Conclusions and Actions

  • Health Canada’s review concluded that there may be a link between the risk of HBV reactivation in patients infected with both HBV and HCV that have been treated with certain DAAs.
  • Health Canada has recommended that the safety information for all DAAs be updated to inform about this risk, as a precaution. In addition, an Information Update will be published to further inform Canadians and health care professionals.
  • Health Canada will continue to monitor safety information involving DAAs, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Original Health Canada post, posted December 1, 2016, can be found here.

Additional Information about this Not from Health Canada

The Liver Meeting 2016 by Hep C Treatments

The Liver Meeting 2016 by Hep C TreatmentsThis post lists all of the topics around hep C treatments presented at the Liver Meeting 2016 by treatment as well as their abstract numbers so that one can easily browse the titles and look them up in the meeting’s online abstracts list, Plenary and Parallel Sessions (Abstracts 1–258).

Treatment: Glecaprevir / Pibrentasvir

  • #73 – ENDURANCE-2: Safety and Efficacy of ABT-493/ABT-530 in Hepatitis C Virus Genotype 2-infected Patients without Cirrhosis, a Randomized, Double-Blind, Placebo-Controlled Study
  • #113 – 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
  • #114 – ENDURANCE-4: Efficacy and Safety of ABT-493/ABT- 530 Treatment in Patients with Chronic HCV Genotype 4, 5, or 6 Infection
  • #253 – ENDURANCE-1: Efficacy and Safety of 8- versus 12-week Treatment with ABT-493/ABT-530 in patients with Chronic HCV Genotype 1 Infection

Treatment: Daclatasvir and Asunaprevir

  • #197 – Complex Pattern of Resistance-Associated Substitutions of Hepatitis C Virus after Treatment failure of Interferon-Free Daclatasvir plus Asunaprevir regimen

Treatment: Sovaldi (Sofosbuvir) and Sovaldi Combos (Included Harvoni and Epclusa)

  • #21 – Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir and Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir-Based Antiviral Regimens for Hepatitis C in 17,847 patients in the Veterans Affairs National Healthcare System
  • #23 – Sofosbuvir/Velpatasvir (SOF/VEL)-Based Regimens are Associated with Excellent Efficacy and a Significant Improvement of Patients-Reported Outcomes (PROs) across Patient Populations: From Non-Cirrhotics to Compensated Cirrhotics to Decompensated Cirrhotics
  • #75 – Integrated Analysis of SOF+RBV, LDV/SOF or SOF/VEL for the Treatment of Genotype 4 Chronic HCV Infection
  • #109 – A Randomized, Controlled, Phase 3 Trial of Sofosbuvir/ Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir for 12 Weeks in Direct Acting Antiviral-Experienced Patients with Genotype 1-6 HCV Infection: The POLARIS-4 Study
  • #194 – Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study
  • #212 – Successful pre- and post liver transplant Sofosbuvir based anti HCV treatment in persons living with HIV infection
  • #213 – Efficacy and safety treating the recurrent hepatitis C post-liver transplantation with simeprevir and sofosbuvir: The Spanish experience (SETH)

Treatment: Zepatier (Grazoprevir/Elbasvir)

  • #74 – C-ISLE: Grazoprevir/Elbasvir plus Sofosbuvir in Treatment- naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks
  • #76 – Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naive Subjects with Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial
  • #110 – Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST-1 & 2)
  • #112 – High Sustained Virologic Response (SVR) Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST-1 & 2)
  • #193 – Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE)

Treatment: Elbasvir

  • #195 – Distinct Evolutionary Pathways of NS5A Inhibitor Resistance in Patients With Genotype 1a Versus 1b Infection During Monotherapy With MK-8742 (Elbasvir)

Treatment: RG-101

  • #111 – RG-101 in Combination with 4 Weeks of Oral Direct Acting Antiviral Therapy Achieves High SVR Rates in Treatment Naïve Genotype 1 and 4 Chronic Hepatitis C Patients

The Liver Meeting 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, was held November 11th – 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, hosted the meeting and, as always, it was exciting.

More information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

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

Hepatitis C Genotypes: The Basics

Hepatitis C Genotypes: The BasicsHepatitis C Genotypes

The hepatitis C virus (HCV) has different types or strains called genotypes. Some resources say eleven hep C genotypes, with several different subtypes, have been identified throughout the world. Only six of them are common. The most common HCV genotype in Canada is HCV genotype 1 (named genotype 1 as it was the first hep C virus type to be discovered). HCV genotype 1 has two sub-genotypes:  1a and 1b.

Did you know?
Most people with the hep C virus are infected by just one virus genotype, BUT a person can be infected with more than one type at the same time. This makes harm reduction and prevention important when someone has hep C.  Prevention and harm reduction work to not only protect those who don’t have hep C, but protects someone from being infected with different genotypes of the virus.

Where the Different Hep C Genotypes are Most Common

  • Genotype 1 in North America
  • Genotypes 1, 2, and 3 globally
  • Genotype 4 in northern Africa
  • Genotype 5 in South Africa
  • Genotype 6 in Asia

Hepatitis C Genotype Testing

To find out what genotype a person with hep C has, blood is drawn at a lab and a HCV RNA test is done to look at parts of the virus’ genetic makeup called nucleotides. As explained above, every hep C genotype has a unique genetic makeup.

Hepatitis C Genotypes and Hep C Treatment

The type of hep C infection one has doesn’t determine how bad their hep C symptoms may be. For example, having HCV genotype 1 doesn’t mean that a person will experience fewer hep C symptoms than someone with genotype 2 hep C. However, hep C genotypes do affect a treatment’s possible success and its side effects. Therefore, right now, each hep C genotype has its own treatments and set of treatment lengths that work best against it. For example, the treatment peginterferon and ribavirin is more likely to work for people who have genotype 2 or 3, and do so with fewer side effects, than they are when those drugs are prescribed to a person with HCV genotype 1. Therefore, every genotype has its own unique treatment.

To be continued…please look out for our upcoming blog posts about hep C geotype 1 treatments and genotype 2-6 treatments.

Additional Resources

Technivie, Zepatier, pCPA, and the Drug Approval Process

Technivie, Zepatier, and the pCPAWhile pan-Canadian Pharmaceutical Alliance (pCPA) negotiations are taking place for two new hepatitis C treatments, Technivie (ombitasvir / paritaprevir / ritonavir) and Zepatier (elbasvir / grazoprevir), there is a bigger discussion going on in Canada that is “…exploring the need for a national formulary…” (CMAJ, May 16, 2016)

A formulary is a health insurance provider’s official list of pharmaceutical drugs that they have approved for coverage. (Merriam-Webster Dictionary)

The Pan-Canadian Pharmaceutical Alliance (pCPA) and the Current System of Individual Provincial / Territorial Drug Formularies

Steps Towards Listing a Treatment

Currently, within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, effectiveness, and how it’s made.

Secondly, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) then assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

Thirdly, according to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, individual provinces/territories may then negotiate with the manufacturer without pCPA or, if the pCPA steps in after deciding that joint pan-Canadian negotiations for the drug will occur, provinces/territories may negotiate collectively.* This happens about 80% of the time. (CMAJ, May 16, 2016)

A province/territory then assumes the lead in the pCPA negotiations, contacts the manufacturer, and starts negotiations. If an agreement about treatment prices is reached, the lead province, the manufacturer, and the other provinces/territories negotiating sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

After a Letter of Intent is signed, the participating jurisdictions will work with the manufacturer on their individual Product Listing Agreement (PLA), or work on a translation of the terms agreed to in the Letter of Intent. This translation is not a second negotiation. After this, the treatment is then listed.

When an Agreement isn’t Reached

However, if negotiations are closed without reaching an agreement, as recently happened with Daklinza (daclatasvir), a treatment for those infected with hep C genotype 1, 2, or 3, provinces/territories involved in the pCPA negotiations can not restart negotiations with the manufacturer on their own.

Once pCPA negotiations are closed, future requests by the provinces/territories for re-consideration start with the treatment’s file being resubmitted to pCPA for further review through their office. In the future, if a manufacture believes that it is “able to provide the value needed by the jurisdictions”**, the manufacturer can also submit an unsolicited offer to the pCPA office and possibly restart negotiations that way. When this happens, provinces/territories are not bound to re-enter pCPA negotiations for the treatment.**

The Current Discussion about Changing the System of Provincial / Territorial Drug Formularies to a National Formulary

Currently, there is talk about changing the system of provincial/territorial drug formularies into a more national pharmacare system. The below are recent articles and videos about this discussion:

*The pCPA also negotiates for military and RCMP employees, First Nations and Inuit people. It is estimated that the pCPA has saved $490 million since 2010.  (CMAJ, May 16, 2016)

**The source of this information was a requested email from the Pan-Canadian Pharmaceutical Alliance and the links within this post.