Direct-acting antivirals, used for hepatitis C, may reactivate hepatitis B

Starting date:

December 1, 2016

Type of communication:

Information Update

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Issue:

Important Safety Information, Microbial Hazard, Disease

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61274

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  Issue
• 
  What you should do
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  What industry professionals should do
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  Report health or safety concerns
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  Media enquiries
• 
  Public enquiries

Issue

OTTAWA – 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.

Related links

• Summary Safety Review: Direct-acting antivirals - Reactivation of Hepatitis B virus infection
• Hepatitis B and Hepatitis C fact sheets - World Health Organisation
• Detailed safety and prescribing information for health professionals and patients is provided in the Canadian Product Monographs for these drugs, which are available by searching the Drug Product Database.

What industry professionals should do

• 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.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709