MAVIRET - AbbVie reaches an agreement with the pan-Canadian For HCV Drug

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for its hepatitis C treatment MAVIRET™

Feb. 21, 2019, 12:09 PM

Ontario will be the first province to reimburse MAVIRET as of February 28, 2019

MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1

MAVIRET previously received positive reimbursement recommendations from the CADTH Canadian Drug Expert Committee (CDEC)2 in January 2018 and the Institut national d'excellence en santé et services sociaux (INESSS) in February 2018

MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, Feb. 21, 2019 /CNW/ - AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced an agreement was reached with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding 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)2. 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. 

Following the positive conclusion with the pCPA, Ontario will be the first province to reimburse MAVIRET on its public formulary as of February 28, 2019. As listed on the Ontario Drug Benefit (ODB)3 Formulary as a Limited Use product, MAVIRET will be covered for treatment-naïve and treatment-experienced adult patients with chronic hepatitis C infection (regardless of fibrosis stage)3:

Laboratory confirmed hepatitis C genotype 1,2,3,4,5,6
HCV RNA value within the last six months

***Prescription by a hepatologist, gastroenterologist or an infectious disease specialist (or other physician experienced in treating hepatitis C).

"After more than 20 years of treating hepatitis C, I am hopeful that soon we will successfully eliminate this virus. But in order to reach this goal in Canada and across the world, we need to work together to test, diagnose and bring these high curative treatments to every individual, regardless of their genotype, fibrosis stage and background," explains Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist, Director of the Toronto Liver Centre. "As a hepatologist, MAVIRET offers me the opportunity to put my patients on an effective, short duration therapy that has a proven track record."

Approximately 300,000 Canadians are infected with hepatitis C.4 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 per cent within 20 years5 of infection. Additionally, HCV is common among people with severe chronic kidney disease (CKD), and some of these patients previously did not have a direct-acting antiviral (DAA)-based treatment option.6

"The Canadian Liver Foundation is committed to seeing Canada meet the target set by the World Health Organization's Global Strategy on Viral Hepatitis. And that target is to eliminate hepatitis C by 2030. It is within our reach, but all our elimination efforts require support, plans and concrete actions at the local level to combat the increasing burden of HCV infection and the associated stigma," says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation and Toronto-based hepatologist. "To be successful, we need a comprehensive screening strategy based on risk factors, plus a one-time test for all Canadians born 1945 – 19757, as well as adapted linkage to care to allow access to all available treatment options for all Canadians."

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).

"AbbVie is committed to the World Health Organization's targets and looks forward to working with governments, health care professionals and patient associations in their concerted efforts to achieve HCV elimination in Canada," explains Stéphane Lassignardie, General Manager, AbbVie Canada. "MAVIRET brings value in order to achieve elimination and all Canadians should have access to innovative and curative therapies."

https://markets.businessinsider.com/news/stocks/abbvie-reaches-an-agreement-with-the-pan-canadian-pharmaceutical-alliance-pcpa-for-its-hepatitis-c-treatment-maviret-1027973100

What's Up Doc?: Hepatitis C, a killer that can be stopped

What's Up Doc?: Hepatitis C, a killer that can be stopped

By Dr. Malavika Varma with Dr. Aravind Ganesh

Hepatitis C (HepC) is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver. The virus can cause both acute (rapid onset) and chronic (long-term) symptoms. Symptoms include a fever, dark urine, abdominal pain, and yellow tinged skin (“jaundice”). Hepatitis C can often lead to liver disease and occasionally cirrhosis. In some cases, it can cause complications such as liver failure, hepatocellular carcinoma (liver cancer), and death.

Read the article: 

https://www.thewhig.com/health/family-child/whats-up-doc-hepatitis-c-a-killer-that-can-be-stopped/wcm/b4b41a2b-2a07-4d3b-8e83-b0797daebd0e

What’s Up, Doc? is a medical column that covers the most interesting doctors, health researchers, and health-care issues or innovations in Canada and in our wider global community.

Updated Guidelines - Hepatitis C testing recommended for Canadians born between 1945 and 1975

Podcast

In this podcast, Dr. Hemant Shah and Dr. Jordan Feld discuss a clinical practice guideline from the Canadian Association for the Study of the Liver on the management of chronic hepatitis C. The guideline is published in the Canadian Medical Association Journal (CMAJ).

Link: https://soundcloud.com/cmajpodcasts/170453-guide

CMAJ Vol. 190, Issue 22 4 Jun 2018

The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver

Hemant Shah, Marc Bilodeau, Kelly W. Burak, Curtis Cooper, Marina Klein, Alnoor Ramji, Dan Smyth and Jordan J. Feld; for the Canadian Association for the Study of the Liver
CMAJ June 04, 2018 190 (22) E677-E687; DOI: https://doi.org/10.1503/cmaj.170453

A recent modelling study suggested that about 252 000 Canadians (uncertainty interval: 178 000–315 000 Canadians) were chronically infected in 2013. The birth cohort of 1945–1975 has the highest prevalence of chronic HCV infection, yet it is estimated that up to 70% of this group have not been tested for HCV 

KEY POINTS

Hepatitis C is a major public health problem in Canada that is underdiagnosed and undertreated; birth cohort screening would benefit population health outcomes.

Pretreatment evaluation of an infected patient should include clinical evaluation, viral load, genotype and a fibrosis stage assessment.

The treatment of hepatitis C has become safer, better tolerated and more effective owing to the availability of direct-acting antivirals for nearly all patients; this guideline advocates against the use of any interferon-based treatment regimens and for the use of all-oral regimens for all infected patients.

The treatment of infected patients should be individualized to maximize chance of success, especially for difficult-to-cure populations, including patients with renal failure, decompensated cirrhosis, and active substance use disorders.

After treatment, the follow-up of successfully treated patients depends on whether they are cirrhotic; patients with cirrhosis require life-long surveillance for the development of hepatocellular cancer.

Chronic hepatitis C virus (HCV) is a highly burdensome public health problem in Canada, causing more years of life lost than any other infectious disease in the country. 1–3 A recent modelling study suggested that about 252 000 Canadians (uncertainty interval: 178 000–315 000 Canadians) were chronically infected in 2013. The birth cohort of 1945–1975 has the highest prevalence of chronic HCV infection, yet it is estimated that up to 70% of this group have not been tested for HCV.4

Although the overall prevalence of chronic hepatitis C is declining, complications of the disease are increasing because of aging of the infected population and progression of liver fibrosis.1–3 Modelling data suggest that if nothing is done to change the current situation, cases of decompensated cirrhosis, hepatocellular carcinoma and liver-related mortality will increase by 80%, 205% and 160%, respectively, by 2035 compared with 2013 levels.2

The primary objective of anti-HCV therapy is complete eradication of the virus, termed a sustained virologic response, which is defined as absence of viremia 12 weeks after completion of therapy. 5 Once achieved, sustained virologic response is considered a true cure of the viral infection, as late relapses are very uncommon. 6,7 Sustained virologic response is associated with long-term health benefits that include improved quality of life8,9 and liver histology, 10,11 and reduced incidence of hepatocellular carcinoma,12 liver-related morbidity and mortality,13–15 and all-cause mortality.12

Since the last Canadian guideline on the management of chronic HCV infection from the Canadian Association for the Study of the Liver was published in 2015,16 there have been remarkable treatment advances. Thus, there was a need for an updated, evidence-based guideline.
Continue reading: http://www.cmaj.ca/content/190/22/E677

In The News
Hepatitis C testing recommended for Canadians born between 1945 and 1975
More than 250,000 Canadians are believed to be infected with hepatitis C, but 40 to 70 per cent are unaware they harbour the blood-borne virus. The Canadian Association for the Study of the Liver, a national group of health-care providers and researchers, published its guidelines on testing and treating hepatitis C in Monday’s edition of the Canadian Medical Association Journal.
Continue reading: http://nationalpost.com/news/canada/hepatitis-c-testing-recommended-for-canadians-born-between-1945-and-1975

Canada launches call for proposals under its Harm Reduction Fund

Government of Canada launches call for proposals under its Harm Reduction Fund
Reducing the risk of HIV, hepatitis C and other blood-borne infections

OTTAWA, May 28, 2018 /CNW/ - Sexually transmitted and blood-borne infections, including HIV and hepatitis C, are largely preventable but remain a significant public health concern in Canada. The Government of Canada is taking action to reduce transmission of these diseases, including measures to prevent the spread of HIV and hepatitis C through the sharing of drug-use equipment, such as needles and pipes.

Through its Harm Reduction Fund, the Public Health Agency of Canada is investing $30 million over five years to support community initiatives to address the risk of infection among people who share drug-use equipment.

Today, the Honourable Ginette Petitpas Taylor, Minister of Health, launched an open call for proposals to support community projects that will reduce the rate of infections of HIV and hepatitis C among people who share injection and other drug-use equipment. Successful projects will implement evidence-based, time-limited interventions such as the development of educational resources for people who use drugs, peer outreach initiatives and training for health service providers.

The open call for proposals will allow applicants to apply for up to three years of funding for time-limited projects.

Quotes
"The Harm Reduction Fund will help organizations implement response activities in communities where there are high rates of infections among people who share drug-use equipment, with the goal of reducing the rates of diseases, like HIV and hepatitis C, across our country."

The Honourable Ginette Petitpas Taylor, P.C., M.P.
Minister of Health

"Evidence shows that harm reduction is a vital part of a comprehensive, compassionate and collaborative public health approach to prevent the transmission of infectious diseases that result from the sharing of drug-use equipment. The Harm Reduction Fund will help Canadians who use drugs to adopt safer behaviours, and will reduce the rate of preventable diseases like HIV and hepatitis C."

Dr. Theresa Tam
Chief Public Health Officer of Canada

Quick Facts
Eligible activities under the Harm Reduction Fund include front-line prevention activities and capacity-building of individuals, providers and systems.
Additional calls for project proposals are planned for spring 2019 and 2020.
People who share drug-use equipment continue to be disproportionately represented among those acquiring HIV and hepatitis C infections in Canada.
In 2014, 10.5% of new HIV infections were among people who injected drugs.
68% of people who inject drugs and who were surveyed between 2010 and 2012 indicated that they had at one point been infected with hepatitis C.

Associated Links
Harm Reduction Fund
Canadian Drugs and Substances Strategy
HIV and AIDS

SOURCE Public Health Agency of Canada

Methadone maintenance therapy and having access to regular physician care regarding HCV among people who inject drugs

The impact of methadone maintenance therapy on access to regular physician care regarding hepatitis C among people who inject drugs

Lianping Ti, María Eugenia Socías, Evan Wood, M-J Milloy, Ekaterina Nosova, Kora DeBeck, Thomas Kerr, Kanna Hayashi

Published: March 26, 2018
https://doi.org/10.1371/journal.pone.0194162

Abstract
Background & aims
People who inject drugs (PWID) living with hepatitis C virus (HCV) infection often experience barriers to accessing HCV treatment and care. New, safer and more effective direct-acting antiviral-based therapies offer an opportunity to scale-up HCV-related services. Methadone maintenance therapy (MMT) programs have been shown to be effective in linking PWID to health and support services, largely in the context of HIV. The objective of the study was to examine the relationship between being enrolled in MMT and having access to regular physician care regarding HCV among HCV antibody-positive PWID in Vancouver, Canada.

Full-Text
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Prescription Drugs : The Costco Kickbacks

Prescription Drugs : The Costco Kickbacks

Secret audio tapes and an exclusive television interview with an industry whistleblower reveal a shady practice that is industry-wide. A Fifth Estate investigation shows how Costco pressed one generic drug company for illegal payments to stock their products -- undermining government attempts to protect consumers.

Watch the program: http://www.cbc.ca/fifth/episodes/2017-2018/prescription-drugs-the-costco-kickbacks

Provincial funding for hepatitis C drugs a game changer, health professionals say

CBC News Provincial funding for hepatitis C drugs a game changer, health professionals say
Changes spurred by development of minimally invasive drugs with extremely high cure rates

Mar 05, 2018
The Ontario government says it will cover the cost of medication for all hepatitis C patients, regardless of the severity of the disease, a move that's being touted as a game-changing decision by health professionals in the field.

Dr. Paul Marotta believes the changes mark a critical turning point for treatment of the disease.

He's a hepatologist and the medical director of the liver transplant program at the London Health Sciences Centre.

"This is probably — hopefully — the final piece of the puzzle," says Marotta.

Continue reading.....

The Canadian Treatment Action Council Launches Campaign to End Hepatitis C in Canada

CTAC Launches Campaign to End Hepatitis C in Canada

TORONTO, Feb. 6, 2018 /CNW/ - The Canadian Treatment Action Council (CTAC) has published a white paper entitled, "The time has come to eliminate hepatitis C in Canada," which summarizes the increasing gaps in Canada's response to the hepatitis C epidemic and identifies seven calls-to-action. CTAC is once again demonstrating its commitment to securing and ensuring access to testing, treatment, care and support for Canadians living with HIV and hepatitis C virus (HCV).

Along with like-minded allies, CTAC is calling upon policymakers and community leaders to respect their engagement to eliminate hepatitis C infection in Canada by adopting a public health strategy and making a clear commitment toward the elimination of viral hepatitis. Commenting on the campaign, CTAC Executive Director Shelina Karmali said, "We're hoping our white paper stimulates a response at all levels of government so that every Canadian managing HCV will have access to equitable and timely testing and treatment." Ms. Karmali added, "HCV is 100 per cent curable."

The Issues
An estimated 220,000 - 245,000 Canadians are infected with HCV. Unfortunately, around 44% of those individuals are unaware of their status, and are often only diagnosed incidentally to something else. There is a large population of individuals currently aging with HCV, whether diagnosed or not, who are now experiencing complications of HCV, some of which are quite severe, such as cirrhosis, liver failure and death. The cost to the healthcare system is greater than treating HCV. Indigenous communities, people who inject drugs, ethno-cultural communities and baby boomers are at an increased risk of being affected by HCV.

In 2016, Canada committed at the WHO to work to eliminate HCV as a public health threat by 2030. Canada's WHO commitment is to have treated 80% of people with the disease. In 2018, hepatitis C prevention and care strategies remain fragmented across the country.

A Unique Opportunity
The goal to cure hepatitis C is achievable, and Canada has had access to these curative medications (highly effective, highly tolerable direct-acting antivirals) since 2015. The pan-Canadian Pharmaceutical Alliance (pCPA) announced in early 2017 a new framework that has brought down the price of treatment. Despite significant treatment cost reductions; too few people are being treated, and in Canada, as elsewhere, hepatitis C rates are on the rise because we have not implemented comprehensive public health strategies to stem the tide.

The 7-Point Solution
There is a role for coordinated national response, including collaboration between federal, provincial and territorial governments, around ending hepatitis C in the next 10 years. CTAC is calling for policymakers and community leaders to adopt a more comprehensive action plan of how hepatitis C elimination will be achieved in Canada by adopting the following:
Increased access to testing, including point-of-care testing, rapid testing, and one-time cohort screening for all baby boomers
Removal of restrictive eligibility requirements to access treatment
Access to all hepatitis C medications approved by Health Canada on public drug programs
Creation of a framework by the pan-Canadian Pharmaceutical Alliance (pCPA) to standardize processes and timelines and add transparency
Removal of the time delay between the close of pCPA negotiations and the signing of Product Listing Agreements with individual provincial and territorial formularies
Lower drug costs
A standalone viral hepatitis plan

Get Involved
CTAC is asking individual and organizational influencers to endorse the calls to action. This can be done electronically by going to www.ctac.ca/EliminateHepC. In addition, for those wishing to take further action, a letter-generated electronic form will be available for submission to individual provincial and territorial health ministers so that a unified voice can be heard and action taken to get Canada back on track toward its stated commitment to eliminate HCV as a public health threat by 2030.

About CTAC
CTAC is Canada's non-governmental organization led by and for people living with HIV and HIV/HCV co-infection, focusing on access to treatment. Since 1996, we have been working to secure and ensure equitable, affordable and timely access to testing, treatment, care and support for people in Canada living with HIV and HIV/HCV co-infection and other co-morbidities. We work with community, public, private and not-for-profit leaders to inform research and public policy, and promote public awareness and discussion.

SOURCE Canadian Treatment Action Council

https://www.newswire.ca/news-releases/ctac-launches-campaign-to-end-hepatitis-c-in-canada-672915243.html
Canadian Treatment Action Council

AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™

AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™ - an oral therapy for the treatment of patients with hepatitis C

MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1
MAVIRET previously received a Notice of Compliance from Health Canada on August 16, 2017
MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, Feb. 6, 2018 /CNW/ - AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that the CADTH Canadian Drug Expert Committee (CDEC) issued a positive recommendation 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)2. 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. 

The recommendation states that glecaprevir/pibrentasvir be reimbursed for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis, including patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors, if specific conditions are met.3

"Continued efforts are fundamental to the ultimate goal of eliminating hepatitis C, which is a serious and complex disease in Canada. It is vital that as many patients as possible are able to achieve a virologic cure, as quickly as possible, and we hope that patients throughout Canada will be able to benefit from this latest treatment, which has the potential to cure most HCV patients in eight weeks," states Dr. Samuel Lee, Hepatologist and Professor, Cumming School of Medicine, University of Calgary.

Approximately 300,000 Canadians are infected with hepatitis C.4 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.5 GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.4,6 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years7 of infection. Additionally, HCV is common among people with severe chronic kidney disease (CKD), and some of these patients previously did not have a direct-acting antiviral (DAA)-based treatment option.8

"Our goal is to see Canada meet its commitment to the World Health Organization's Global Strategy on Viral Hepatitis by eliminating hepatitis C by 2030. This is within our reach, but we need a coordinated national response with a comprehensive action plan to prevent, screen, diagnose and treat Canadians living with hepatitis C," says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation and Toronto-based hepatologist. "The Canadian Liver Foundation recommends screening for hepatitis C based on risk factors, plus a one-time test for all Canadians born 1945 – 19759. Furthermore, treatment eligibility restrictions that currently exist need to be removed, so that physicians and their patients have affordable and equitable access to all available treatment options, regardless of background, disease severity or the province in which they live."

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).

"AbbVie is deeply committed to curing Canadians of hepatitis C. We strongly believe in providing patient and doctor choice when selecting the appropriate medication," explains Stéphane Lassignardie, General Manager, AbbVie Canada. "The CADTH positive recommendation reinforces our belief that there is a need for innovative therapies like MAVIRET in order to reach the goal set out by the World Health Organization to eliminate HCV by 2030 in Canada and across the world."

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,*1 such patients comprising the majority of people living with HCV. 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 and development-based 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 CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed February 2018.
4Messina, JP et al. "Global distribution and prevalence of hepatitis C virus genotypes." Hepatology, 2015; 61: 77–87. Supporting information http://onlinelibrary.wiley.com/wol1/doi/10.1002/hep.27259/full. Accessed January 2018.
5 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 February 2018.
6 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.
7 Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 2018.
8 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
9 The Canadian Liver Foundation, press release: https://www.newswire.ca/news-releases/not-getting-the-message-too-many-canadians-born-between-1945-1975-unaware-of-their-increased-risk-of-undiagnosed-hepatitis-c-587783871.html. Accessed February 2018.

SOURCE AbbVie Canada

Population-based estimate of hepatitis C virus prevalence in Ontario, Canada

PLoS One. 2018

Population-based estimate of hepatitis C virus prevalence in Ontario, Canada

Shelly Bolotin , Jordan J. Feld, Gary Garber, William W. L. Wong, Fiona M. Guerra, Tony Mazzulli Published: January 23, 2018

https://doi.org/10.1371/journal.pone.0191184

Abstract
Background
Hepatitis C virus (HCV) is the most burdensome infectious illness in Canada. Current screening strategies miss a significant proportion of cases, leaving many undiagnosed. Elevated HCV prevalence in those born between 1945 and 1965 has prompted calls for birth-cohort screening in this group. However, Canada lacks population-level data to support this recommendation. We performed a serosurvey to obtain population-based HCV prevalence estimates in Ontario residents born between 1945–1974, to generate evidence for birth-cohort screening recommendations.

Methods
We tested anonymized residual sera in five-year age-sex bands from Ontario for anti-HCV antibody. We performed descriptive epidemiological analysis and used a logistic regression model to determine HCV risk-factors.

Results
Of 10,006 sera analyzed, 155 (1.55%, 95% confidence interval (CI) 1.32, 1.81) were positive for HCV antibody. Individuals born between 1950–1964 had a significantly higher combined prevalence of 1.92% (95% CI 1.56, 2.34) compared to 1.14% (95% CI 0.69, 1.77) (p = 0.04) for those born between 1970–1974. For males, comprising 107/155 (69.03%) of positive samples, the highest prevalence was 3.00% (95% CI 1.95, 4.39) for the 1960–1964 birth-cohort. For females, the highest prevalence was 1.56% (95% CI 0.83, 2.65) for those born between 1955–1959. Male sex was significantly associated with positive HCV serostatus.

Interpretation
HCV prevalence in Ontario is highest among those in this birth cohort, and higher than previous estimates. The prevalence estimates presented in our study provide important data to underpin birth-cohort screening recommendations.

Full Text: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191184

Podcast: What it will take for hepatitis C to be cured in Canada

AMI Podcast
November 13, 2017 episode
2017 World Hepatitis Summit

Hepatitis C in Canada 
Dr. Jordan Feld from the Toronto Centre for Liver Disease discuss what it will take for hepatitis C to be cured in Canada.

Of all infectious disease in Canada the one disease that causes most years of life lost is hepatitis C. 

Listen here......

Hepatitis C Virus (HCV) diagnosis, epidemiology and access to treatment in a UK cohort

New Results
Hepatitis C Virus (HCV) diagnosis, epidemiology and access to treatment in a UK cohort

Emily Adland, Gerald Jesuthasan, Louise Downs, Victoria Wharton, Gemma Wilde, Anna McNaughton, Jane Collier, Eleanor Barnes, Paul Klenerman, Monique Andersson, Katie Jeffery, Philippa Matthews

doi: https://doi.org/10.1101/216937

Posted November 10, 2017.

Full Text

PDF Download

Abstract

Background: As direct acting antiviral (DAA) therapy is progressively rolled out for patients with hepatitis C virus (HCV) infection, careful scrutiny of HCV epidemiology, diagnostic testing, and access to care is crucial to underpin improvements in delivery of treatment.

Methods: We performed a retrospective study of HCV infection in a UK teaching hospital to evaluate the performance of different diagnostic laboratory tests, to describe the population with active HCV infection, and to determine the proportion of these individuals who access clinical care. Results: Over a total time period of 33 months between 2013 and 2016, we tested 38,510 individuals for HCV infection and confirmed a new diagnosis of active HCV infection (HCV-Ag+ and/or HCV RNA+) in 359 (positive rate 0.9%). Our in-house HCV-Ab test had a positive predictive value of 87% when compared to repeat HCV-Ab testing in a regional reference laboratory, highlighting the potential for false positives to arise based on a single round of antibody-based screening. Of those confirmed Ab-positive, 70% were HCV RNA positive. HCV-Ag screening performed well, with 100% positive predictive value compared to detection of HCV RNA. There was a strong correlation between quantitative HCV-Ag and HCV RNA viral load (p<0.0001). Among the 359 cases of infection, the median age was 37 years, 85% were male, and 36% were in prison. Among 250 infections for which genotype was available, HCV genotype-1 (n=110) and genotype-3 (n=111) accounted for the majority. 117/359 (33%) attended a clinic appointment and 48 (13%) had curative treatment defined as sustained virologic response at 12 weeks (SVR12).

Conclusions: HCV-Ab tests should be interpreted with caution as an indicator of population prevalence of HCV infection, both as a result of the detection of individuals who have cleared infection and due to false positive test results. We demonstrate that active HCV infection is over-represented among men and in the prison population. A minority of patients with a diagnosis of HCV infection access clinical care and therapy; enhanced efforts are required to target diagnosis and providing linkage to clinical care within high risk populations.

https://www.biorxiv.org/content/biorxiv/early/2017/11/10/216937.full.pdf

Hepatitis C is a huge public health problem in Canada

Hepatitis C could be eliminated in Canada, but drug prices, screening barriers stand in the way
By Nicole Ireland, CBC News Posted: Nov 03, 2017 1:42 AM ET

In a presentation to the World Hepatitis Summit in Sao Paulo on Thursday, Hill said 90 per cent of hepatitis C patients can now be cured in 12 weeks, at a cost of about $50 US per patient...

For Feld, the larger barrier to curing the estimated 250,000 people infected with the virus in this country is the absence of a "targeted, well-structured national plan" to actually reach those patients...

Feld advocates broadening screening in Canada to everyone born between 1945 and 1975 — a practice recommended by the Canadian Liver Foundation but rejected by the Canadian Task Force on Preventive Health Care....

Read more... http://www.cbc.ca/news/health/hepatitis-c-can-be-cured-in-canada-1.4385172?cmp=rss

Gilead Receives Approval in Canada for Expanded Indication of EPCLUSA® for Chronic Hepatitis C in Patients Co-Infected with HIV

Gilead Receives Approval in Canada for Expanded Indication of EPCLUSA® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV

– New Data for First Approved Pan-genotypic Once-Daily Single Tablet Regimen for
Chronic Hepatitis C Virus Infection –

MISSISSAUGA, ON, Sept. 21, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for updated labeling of EPCLUSA® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV-1. Health Canada granted EPCLUSA an NOC in July 2016, for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.

"HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded indication, EPCLUSA provides co-infected patients with a much-needed one-pill-a-day regimen that works across all HCV genotypes and at all stages of disease. Being compatible with most widely-used antiretroviral regimens adds to its convenience," said Dr. Brian Conway, President and Medical Director, Vancouver Infectious Diseases Centre. "With EPCLUSA, physicians have an important new treatment option for their HCV/HIV co-infected patients."
The supplemental new drug submission was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with EPCLUSA in 106 subjects with genotype 1-4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. In the study, 95 per cent (101/106) of patients achieved the primary endpoint of SVR12, defined as an undetectable viral load 12 weeks after completing therapy. The study also included patients with compensated cirrhosis.

The safety profile of EPCLUSA in HCV/HIV co-infected patients was similar to that observed in HCV mono-infected patients. The most common adverse events (in at least 10 per cent of subjects) were fatigue (22 per cent) and headache (10 per cent).

"Canada has committed to eliminating hepatitis C by 2030. To accomplish this goal, it is imperative that steps be taken to increase treatment rates in Canada, including treatment for people who are co-infected with hepatitis C and HIV," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital. "Hepatitis C progresses faster in individuals who are co-infected with HIV, often increasing and speeding up the onset of liver damage. Today, with pan-genotypic curative hepatitis C therapies approved for treatment in hepatitis C and HIV co-infected patients, it is an important time for patients to discuss treatment options with their health care providers."

"EPCLUSA has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV co-infected patients can benefit from this pan-genotypic single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada. "This approval advances the commitment we've made to the HCV and HIV communities to deliver innovative new treatments that address their unmet medical needs."
http://www.newswire.ca/news-releases/gilead-receives-approval-in-canada-for-expanded-indication-of-epclusa-sofosbuvirvelpatasvir-for-the-treatment-of-chronic-hepatitis-c-in-patients-co-infected-with-hiv-646369933.html

Health and economic effects of screening for hepatitis C in Canada

Recommended Reading
April 24, 2017
New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system
The Canadian Task Force on Preventive Health Care recommends against screening for chronic hepatitis C virus (HCV) in adults at low risk in a guideline published in CMAJ (Canadian Medical
Association Journal).

In case you missed it.

Model-based projection of health and economic effects of screening for hepatitis C in Canada

William W.L. Wong, PhD, Aysegul Erman, MSc, Jordan J. Feld, MD, Murray Krahn, MD, MSc

Full Text Journal Article

View Online

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Antivir Ther. 2017 Aug 11. doi: 10.3851/IMP3186. [Epub ahead of print]

Abstract

BACKGROUND:
Because most hepatitis C virus (HCV) infections are asymptomatic and often unrecognized, screening for hepatitis C has been proposed as a plausible public health strategy. We examined the health and economic consequences of a selective one-time hepatitis C screening program for specific populations in the context of current treatment patterns.

METHODS:
We used a state-transition model to evaluate 2 general strategies: no screening, and screen and treat with direct-acting antiviral agents. We examined these strategies for 4 different target populations (scenarios): 1) asymptomatic people not at high risk for HCV infection, 2) immigrant populations with high prevalence, 3) a birth cohort of people aged 25-64 years and 4) a birth cohort of people aged 45-64 years of age. We obtained model data from the published literature and expert opinions. We used a payer perspective, a lifetime time horizon and a 5% discount rate.

RESULTS:
Screening would prevent 49.7%, 57.4%, 64.1% and 49.6% of HCV-related deaths over the lifetime of the cohort for scenarios 1, 2, 3 and 4, respectively. Screening would produce incremental-cost-effectiveness ratios between $31 468/quality-adjusted life-year and $50 490/quality-adjusted life-year. Probabilistic sensitivity analyses indicated that the chance that screening would be cost-effective at $50 000 willingness-to-pay threshold was 39.5%, 63.2%, 58.4% and 58.1% for scenarios 1, 2, 3 and 4, respectively.

INTERPRETATION:
Our analyses suggest that a one-time hepatitis C screening and treatment program in Canada is likely to be cost-effective for scenarios 2, 3 and 4. The screening programs we have evaluated would identify asymptomatic people with chronic HCV infection and would enable medical treatment to be offered if needed before the development of advanced liver disease.

Continue to full text article....

Gilead's VOSEVI HCV Regimen for Re-Treatment Receives Health Canada Approval

Gilead Receives Health Canada Approval for the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment
August 17, 2017

Deb Schmitz
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

View all information, here..

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.

AbbVie's MAVIRET Approved by Health Canada

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

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

New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system

New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system

Reliance on risk-based testing will perpetuate low diagnosis rates and increases in cirrhosis and liver cancer 

Toronto, April 24, 2017: They may not look sick. They may not feel sick. And yet many Canadians in the prime of their lives are living with a potentially fatal liver disease -- hepatitis C. An estimated 44 percent of Canadians with hepatitis C have no idea that they have it. Unfortunately, the Canadian Task Force on Preventive Health Care’s  (CTFPHC) new screening guidelines released today recommend against screening of adults without identifiable risk factors which may result in the bulk of the age group most at risk of having chronic hepatitis C (those born between 1945 and 1975) remaining undiagnosed.

“Liver cancer rates are rising in Canada due in large part to late diagnosis and lack of treatment of hepatitis C,” says Dr. Morris Sherman, Chairperson of the Canadian Liver Foundation and a practicing hepatologist. “While we congratulate CTFPHC’s commitment to hepatitis C testing, the truth is that risk-based testing, which was first recommended in 2009  has only been effective in identifying a small proportion of adults with recognized risk factors. If you or your doctor don’t think you have any risk factors then according to these guidelines you won’t be tested.  We are disappointed that, despite widespread support among medical experts and advocacy groups, the CTFPHC failed to establish new  guidelines which would encourage widespread screening not just based on risk factors but also by age.”

In August 2012, the U.S. Centers for Disease Control and Prevention issued its recommendation that all adults born between 1945 and 1965 should have a one-time hepatitis C test. Based on the prevalence data in Canada and taking into account immigration from countries where hepatitis C is endemic, the Canadian Liver Foundation believed the age bracket should be expanded and issued its own recommendations that same year that adults born between 1945 and 1975 be tested. In 2013, the Public Health Agency of Canada (PHAC) began reviewing its screening guidelines for hepatitis C, but no new guidelines were issued. Subsequently, PHAC tasked the CTFPHC with reviewing evidence and coming up with recommendations.

The new CTFPHC guidelines call for screening of adults with known risk factors including blood transfusions prior to 1992, past or present injection drug use, and coming from certain countries where hepatitis C is endemic. The  guidelines strongly recommend against screening for those without recognized risk factors meaning that if a person is not aware of a situation in which they may have been exposed to hepatitis C (i.e. from contaminated medical equipment, a common source of transmission in other countries) then they will not qualify for testing.

“The CTFPHC expressed concern over the costs of testing such a large group, the potential for false positives and the mental distress that a diagnosis might cause,” says Dr. Sherman. “But don’t we have an obligation to inform people if they have a potentially fatal but curable disease?”

Data suggests that age-based screening of adults born between 1945 and 1975 could capture as much as 77 percent of the population living with undiagnosed hepatitis C.1  Age-based screening is also cost-effective based on a reduction in deaths due to hepatitis C,  increases in quality of life years and savings in acute care costs for those with advanced disease.2  While the cost of treatment has previously been an obstacle, recent negotiations by the Pan-Canadian Pharmaceutical Alliance (pCPA) have successfully reduced the cost of several of the leading hepatitis C drug therapies.

“The CTFPHC guidelines wrongly assume that the majority of those with hepatitis C would only have early stage disease,” says Dr. Sherman, “when in fact most have been living with it for decades. They do not adequately acknowledge the tragic personal costs and the health system costs of these individuals being diagnosed only when they have progressed to cirrhosis, liver cancer or liver failure. They over-estimate the potential harms of screening and fail to recognize the potential harms of not screening – the missed opportunities to save lives and to save downstream costs  to the health care system for liver transplants and acute care for those suffering from advanced hepatitis C.”

In 2016, the federal Health Minister Dr. Jane Philpott publicly committed to the World Health Organization’s goal of eliminating hepatitis C by 2030. Canada’s dismal diagnosis rates are due in part to risk-based screening which has been in place for years. The CTFPHC’s  long-awaited screening guidelines maintain the status quo which will leave tens of thousands still undiagnosed. We therefore call upon Minister Philpott to ask CTFPHC to reconsider their guidelines or justify how the continued reliance on risk-based screening only will achieve her commitment to eliminate hepatitis C.
http://www.liver.ca/newsroom/press-releases/04-24-2017_Hep_C_screening_guidelines.aspx

Hepatitis C: New Canadian guidelines recommend against screening low-risk adults

New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system
New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system. Reliance on risk-based testing will perpetuate low diagnosis rates and increases in cirrhosis and liver cancer

Continue reading....

Hepatitis C: New Canadian guidelines recommend against screening low-risk adults

The Canadian Task Force on Preventive Health Care recommends against screening for chronic hepatitis C virus (HCV) in adults at low risk in a guideline published in CMAJ (Canadian Medical
Association Journal).

“Given the lack of direct evidence that mass screening is beneficial and that patients identified by screening will either never develop symptoms of hepatitis C, or will remain well for decades after infection, we have recommended against screening for HCV in adults who are not at elevated risk,” said Dr. Roland Grad, member of the task force and chair of the guideline work group.

This is the first hepatitis C screening guideline from the task force. The task force looked for the highest-quality scientific evidence available about the effectiveness (benefits and harms) of screening to develop its recommendation. The recommendation is based on the following:

• the low prevalence of hepatitis C in Canada among the general adult population not at elevated risk for chronic infection;
• the lack of direct evidence on the benefits and harms of screening;
• many individuals with chronic hepatitis C identified by screening would not have timely access to anti-viral treatment;
• the potential for harms caused by screening could include labeling, stigma, and difficulties with insurance;
• the low risk of household and sexual transmission of HCV among individuals not at elevated risk, as well as the low risk of transmission through blood products given routine screening of blood and organs; and
• the anticipated increase in harm resulting from diagnosing and treating individuals who screen positive, but would have never developed HCV-related disease during their lifetime.

This recommendation is for people who are not at increased risk of hepatitis C. It does not apply to pregnant women or people at increased risk, including:

• people with current or past history of injection drug use;
• people who have been in jail;
• people who were born, travelled or lived in hepatitis C endemic countries;
• people who have received health care where there is a lack of universal precautions to protect against viral transmission;
• recipients of blood transfusions, blood products or an organ transplant before 1992 in Canada;
• hemodialysis patients;
• people who have had needle stick injuries;
• people who have engaged in other behaviours associated with hepatitis C exposure such as high-risk sexual behaviour, homelessness, intranasal and inhalation drug use, tattooing, body piercing or sharing sharp instruments or personal hygiene materials with someone who is hepatitis C-positive; and
• anyone with clinical clues suspicious for hepatitis C infection.

“The HCV prevalence in most adults in the general Canadian population is low and direct evidence examining the benefits and harms of screening for HCV is not available,” write the authors. “Not screening for HCV [in the general population] will help focus our limited health care resources to test (and treat) individuals at elevated risk for HCV and to provide other medical interventions that are of proven to be of benefit.”

http://outbreaknewstoday.com/hepatitis-c-new-canadian-guidelines-recommend-screening-low-risk-adults-31699/

EPCLUSA™ - Alberta Also Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions

-- Alberta Also Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions --

MISSISSAUGA, ON , April 3, 2017 /CNW/ - Gilead Sciences Canada, Inc. ( Gilead Canada ) today announced, effective immediately, Alberta will provide public access to EPCLUSA™ (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030.

EPCLUSA, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV.

The approval of EPCLUSA was supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. Of the 1,035 patients without cirrhosis or with compensated cirrhosis treated with EPCLUSA for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent) achieved SVR12 (sustained virologic response 12 weeks after the end of treatment). In ASTRAL-4, patients with decompensated cirrhosis who received EPCLUSA with RBV for 12 weeks achieved a high SVR12 rate (94 per cent) compared to those who received EPCLUSA for 12 weeks or 24 weeks without RBV (83 per cent and 86 per cent, respectively). The most common adverse events in the four ASTRAL studies were headache and fatigue, and were comparable in incidence to the placebo group included in ASTRAL-1.

The listing in Alberta follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, Alberta will expand access to include patients with less advanced disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement.

For more information on the expanded access criteria:
https://www.ab.bluecross.ca/dbl/pdfs/dbl_full_list.pdf

"We now have the ability to cure almost all patients with chronic HCV with a simple and safe 12-week treatment, regardless of viral genotype or patient history," said Dr. Stephen Shafran , Professor of Medicine, Division of Infectious Disease, University of Alberta. "Broader access to EPCLUSA, particularly at the earlier stage of the disease, means that we can move more quickly to help patients achieve a cure, improve their quality of life, and prevent cases of advanced liver disease that is a significant financial burden for the healthcare system."

In Alberta , the Public Health Agency of Canada estimates that more than 24,000 people are living with chronic HCV. In Canada, it is estimated that 250,000 Canadians are living with chronic HCV, with thousands of new cases diagnosed each year. There are six genotypes of hepatitis C. Genotype 1 infection is the most prevalent genotype in Canada representing 64.1 per cent of infected individuals. Genotypes 2 and 3 account for approximately 14.1 per cent and 20.2 per cent of infections in Canada , whereas genotypes 4, 5, and 6 are less prevalent in Canada (0.3 per cent).

"Canada, and other countries, have committed to eliminating hepatitis C by 2030, and to accomplish this goal we need to significantly increase treatment rates," said Dr. Morris Sherman , Chairperson, Canadian Liver Foundation and hepatologist at Toronto General Hospital. "Treatment regimens are getting shorter, simpler and more widely effective across genotypes meaning that treatment is now easier for both patients and physicians to manage.

"Currently, an estimated 44 per cent still remain undiagnosed, so increasing treatment rates also means improving screening and diagnosis, which is why the Canadian Liver Foundation recommends that all Canadians born between 1945-1975 receive a one-time test for hepatitis C," added Dr. Sherman. "Treatment should be an option for everyone, but the cost of treatment has been an obstacle. We're glad to see that the pCPA and the provinces are taking steps to make these treatments accessible regardless of where someone lives or their ability to pay."

" Gilead Canada is pleased that the pCPA and Alberta Health are recognizing the innovation and clinical value of EPCLUSA for the treatment of all genotypes of hepatitis C in a single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada . "Broader treatment access for patients will potentially have a profound impact on disease elimination efforts in Canada , and supporting such efforts is a key priority for our company. We will continue to work closely with all jurisdictions to bring this simple and cost-effective curative treatment to all eligible patients, regardless of their genotype or stage of fibrosis."

http://finance.yahoo.com/news/alberta-lists-epclusa-public-drug-151000019.html