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Hep C Update

Health Canada Warning: Direct-Acting Antivirals May Cause Hep B Reactivation

December 7th, 2016 at 1:51 pm

healthcanada

OTTAWA, Dec. 1, 2016 /CNW/ – A recent Health Canada safety review found that patients infected with both hepatitis B and hepatitis C viruses who are being treated for hepatitis C with direct-acting antivirals may experience a reactivation of their hepatitis B. Hepatitis B reactivation is the return of an active hepatitis B infection, which can lead to serious complications such as liver failure.

As a result, Health Canada is working with manufacturers to strengthen the prescribing information for these drugs with a new warning about this risk.

Direct-acting antivirals are prescription medicines used to treat and, in most cases, cure chronic hepatitis C virus infections in adults. Without treatment, chronic hepatitis C virus infections can lead to serious liver problems, including cirrhosis (liver scarring), liver cancer and death.

When Health Canada completed its safety review in October 2016 there were no Canadian cases of hepatitis B reactivation. However, 13 international cases were identified. In some cases, the symptoms reported were consistent with moderate to severe hepatitis B reactivation, with one case resulting in liver failure requiring a liver transplant.

Health Canada will continue to monitor and evaluate the risk of hepatitis B reactivation associated with the use of direct-acting antivirals. If new safety information is identified, Canadians will be updated, as required.

The direct-acting antivirals available in Canada are:

  • Daklinza (daclatasvir)
  • Epclusa (sofosbuvir, velpatasvir)
  • Galexos (simeprevir)
  • Harvoni (sofosbuvir, ledipasvir)
  • Holkira Pak (dasabuvir, paritaprevir, ombitasvir, ritonavir)
  • Sovaldi (sofosbuvir)
  • Sunvepra (asunaprevir)
  • Technivie (paritaprevir, ombitasvir, ritonavir)
  • Zepatier (grazoprevir, elbasvir)

 

What you should do:

  • Tell your health care professional if you currently have or have ever had hepatitis B, or if you have other liver problems (such as cirrhosis), before starting treatment with direct-acting antivirals.
  • Talk to your health care professional if you have questions or concerns about using direct-acting antivirals.
  • Do not stop taking direct-acting antivirals without talking to your health care professional.

Information for healthcare professionals:

  • Healthcare professionals should screen all patients for past or current hepatitis B infections before starting direct-acting antiviral therapy for hepatitis C.
  • Patients with past or current hepatitis B infections who are receiving direct-acting antiviral therapy should be monitored both during treatment and during post-treatment follow-up. Monitoring should include watching for clinical signs and reviewing laboratory findings related to hepatitis flare or hepatitis B reactivation.

Report health or safety concerns
To report a side effect to a health product to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related links:

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Également disponible en français

 

SOURCE Health Canada

Call to Action for Strategy to Eliminate Hep C

September 29th, 2016 at 12:03 pm

hepcpetition

To help raise political awareness for a strategy to eliminate hepatitis C Action Hepatitis Canada has started an official Parliamentary Petition. The petition requires 500 signatures. Members of Parliament will be presented with AHC’s request for a National Strategy in the House of Commons. To sign go to this link. 

Canada Reaffirms its Commitment to Battling Viral Hepatitis

June 16th, 2016 at 3:56 pm

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OTTAWA, June 16, 2016 – The Honourable Jane Philpott, Canada’s minister for health, reaffirmed today Canada’s commitment to participate in the global fight against viral hepatitis.

Speaking at a breakfast on Parliament Hill organized by the Canadian Society for International Health (CSIH), Philpott said to the health professionals, government officials, civil society representatives and hepatitis survivors in attendance,  “We are committed to do the work to end hepatitis as a public health threat by 2030. We are working closely with provinces and territories to address the ongoing burden of viral hepatitis.”

Canada, along with 193 other Member States, recently adopted the Global Strategy on Viral Hepatitis at the World Health Assembly in Geneva, Switzerland. The goal – the elimination of hepatitis B and C by 2030 – signals the greatest ever global commitment on viral hepatitis.

The Parliamentary Breakfast also marked the launch of the World Hepatitis Day campaign in Canada.  WHD, celebrated annually on July 28, is dedicated to raising awareness about viral hepatitis and promoting prevention, and access to testing, treatment and care. Again this year, the Canadian campaign is spearheaded by CSIH and links some 65 organizations planning more than 100 events across the country. This year’s theme is: Know your status? Get tested. Know your options.

Quotes:

“Hepatitis is not just somebody else’s problem. Thousands of Canadians may be affected by the virus and not know it yet. We urge everyone to get informed and get tested.” Eva Slawecki, Executive Director, CSIH

“The adoption of the Global Strategy is a milestone in the fight against viral hepatitis. It is now up to every country that signed on, including Canada, to do what it takes to eliminate these diseases.” Dr. Curtis Cooper, Director of The Ottawa Hospital Regional Viral Hepatitis Program.

Facts:

  • Viral hepatitis is an inflammation of the liver caused by one of five hepatitis viruses. Hepatitis B and C may lead to liver failure, cancer, disability and death.
  • There are some 600,000 Canadians living with hepatitis, many of whom are unaware of their condition. Worldwide, more than 400 million people are infected, and 1.4 million die every year from the condition – more than HIV/AIDS or malaria.
  • For more information on the Global Strategy on Viral Hepatitis: http://www.who.int/mediacentre/news/releases/2016/wha69-28-may-2016/en/

CSIH: The Canadian Society for International Health (CSIH) brings the Canadian global health community together to better achieve a shared goal of improving health worldwide. www.csih.org

Hepatitis C Traceable to Post War Hospital Care in North America

April 6th, 2016 at 8:37 am

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If you have lived a relatively clean life, you might think the odds of your suffering from hepatitis C might be as small as the odds of winning a lottery, but a study released last week indicates that just being a baby boomer is a risk factor.

This is a lottery you wouldn’t want to win. Getting tested for the virus, as recommended by Dr. Julio Montaner, director of the B.C. Centre of Excellence in HIV/AIDS, is a small price to pay for health and peace of mind.

Hepatitis C has long been associated with risky lifestyles — particularly indiscriminate sexual activity, dodgy tattoo procedures or the injection of recreational drugs — with symptoms of the disease sometimes showing up decades after the initial infection. Those are still high-risk factors, but a study released last week dispels the notion that the virus hits only those who were careless during the Summer of Love or who now live risky lifestyles.

The study, undertaken by the Centre of Excellence with the U.S. Centers for Disease Control, discovered the hepatitis C epidemic in North America peaked between 1940 and 1965, with most of those infected coming into contact with the disease in hospitals and by improperly sterilized medical syringes.

Advancements in medical procedures, as well as improved screening of blood products, have helped stem the spread of the virus, but anyone born between 1945 and 1964 is considered to be at risk of carrying the disease.

“Based on our results, the oldest members of the demographic cohort with the highest burden of hepatitis C virus (the baby boomers) were roughly five years of age around the peak of the spreads of genotype 1a in North America in 1950,” wrote the authors of the study. “Thus, it is unlikely that past sporadic risky behaviour … was the dominant route of transmission in this group.”

A 2014 Canada Communicable Disease Report estimated 240,000 Canadians were living with chronic hepatitis C in 2011. Cynthia Carter, a Saanich volunteer with the B.C. Hepatitis C Education and Prevention Society, says B.C. residents account for a disproportionately large chunk at about 80,000.

The sex-and-drug link has led to a stigma against testing among groups thought to be at low risk of infection. The result of that attitude, says the Public Health Agency of Canada, is that 44 per cent of Canadians with hepatitis C are not aware that they are infected and spreading the disease.

“Any baby boomer could be living with HCV [hepatitis C virus], even in the absence of symptoms or any history of high-risk behaviours, and as such they should be encouraged to proactively seek HCV testing,” Montaner says.

Typically, hepatitis C shows no symptoms at the time of infection and takes decades to do its damage. But 75 to 85 per cent of people with HCV develop chronic hepatitis, according to the U.S. Centers for Disease Control and Prevention. Some of those infected outlive the virus and live healthy lives, but up to 20 per cent develop cirrhosis, an incurable disease, and one to five per cent will die of liver disease or liver cancer.

“Hepatitis C is a time bomb, and it’s obviously not being addressed appropriately,” Montaner says.

Provinces and territories should provide screening to detect the disease, which is curable in up to 95 per cent of cases, he says.

Hepatitis C is referred to as a hidden epidemic, because so many carriers aren’t aware they have the disease. But this is an epidemic we can avert — through proper screening and treatment, where necessary.


© Copyright Times Colonist – See more at: http://www.timescolonist.com/opinion/editorials/editorial-hep-c-epidemic-can-be-stemmed-1.2223657#sthash.rnqAtaTo.dpuf

FDA Approval for Expanding Use of Harvoni in Hep C Patients

February 19th, 2016 at 9:28 am

harvoni

The FDA approved Harvoni (ledipasvir/sofosbuvir) for two new indications that will expand its use in liver transplant patients with HCV as well as those with decompensated cirrhosis, who generally have a poor prognosis and often go on to require a liver transplant.

Previously treatment options in these patients have been limited and often involved injectable and hard-to-tolerate interferon alpha therapy. Now they will be able to receive a 12-week, oral course of Harvoni, expanding the target patient population for a drug that brought in nearly $14bn in sales last year.

Specifically, the US regulator has approved Harvoni in combination with ribavirin chronic HCV genotype (GT) 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis, as well as for GT 1-infected patients with decompensated cirrhosis, including those who have received a liver transplant.

Gilead has been expanding the use of Harvoni as the drug starts to face competition from rival oral HCV therapies, including AbbVie’sViekirax/Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) and Merck & Co’s recently-approved Zepatier (elbasvir/grazoprevir), which has undercut Harvoni on price.

Last November, the FDA approved Harvoni for expanded use in patients with genotype 4, 5, and 6 chronic HCV infections and in patients co-infected with HIV. It also cleared a 12-week Harvoni and ribavirin regimen as an alternate therapy to 24 weeks of Harvoni for treatment-experienced genotype 1 patients with cirrhosis.

All told, Harvoni and Sovaldi (sofosbuvir) have been used to treat more than 750,000 patients with HCV around the world and the success of the new oral HCV therapies have raised the real prospect of eradicating HCV.

Despite the number of patients treated to date, there are still millions of HCV-infected individuals who have yet to be treated and many that have yet to be diagnosed, according to Gilead, which believes HCV will remain a sustainable market for the foreseeable future.

The company is also hoping to launch a follow-up to Harvoni, which covers a broader range of HCV genotypes and should extend the franchise.

PMLive