ADR that result in revision of patient information
|
| |
| Canada: Summary Safety Review: Direct-acting antiviral products containing a protease inhibitor: Assessing the potential risks of hepatic decompensation and hepatic failure |
| |
Health Canada announces that it reviewed the potential risk of worsening liver function and liver failure with the use of direct-acting antiviral products containing a protease inhibitor. The safety review was triggered by a United States Food and Drug Administration (FDA) Drug Safety Communication warning about these risks in chronic hepatitis C virus-infected patients with advanced liver disease.
Direct-acting antiviral products containing a protease inhibitor are prescription drugs authorized for sale in Canada to treat chronic hepatitis C virus infection. At the time of this review, Maviret (glecaprevir/pibrentasvir), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and Zepatier (grazoprevir/elbasvir) are authorized for sale in Canada as fixed dose combination products.
Health Canada reviewed information from searches of the Canada Vigilance database, international databases, from manufacturers and published scientific and medical literature. At the time of the review, Health Canada had received 53 case reports for Maviret (1 Canadian), 23 case reports for Vosevi (6 Canadian) and 18 case reports for Zepatier (1 Canadian) related to worsening liver function and liver failure. Health Canada's review found that there may be a link between the use of direct-acting antiviral products containing a protease inhibitor and worsening liver function and liver failure. For Maviret, 51 cases (1 Canadian) showed a possible link and 2 cases could not be assessed due to insufficient information in the reports. For Vosevi, 15 cases (3 Canadian) were found to be possibly linked, 1 case was not likely to be linked, and 7 cases (3 Canadian) did not have enough information to be assessed. For Zepatier, 16 cases (1 Canadian) were considered possibly linked, and 2 cases could not be assessed due to insufficient information in the reports. For most of these cases, contributing factors including existing medical conditions and other medications taken by the patient could not be ruled out. Pre-existing significant liver disease was present in all of the cases. Health Canada also reviewed 2 studies from the published scientific literature. These studies did not provide additional information beyond what was obtained from the above case reports.
Health Canada's review concluded that there may be a link between the use of direct-acting antiviral products containing a protease inhibitor and the risks of worsening liver function and liver failure in some patients with pre-existing significant liver disease. Health Canada has requested that the manufacturers of direct-acting antiviral products containing a protease inhibitor update the Canadian product safety information to include information about these risks.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00249
In Hong Kong, there are registered pharmaceutical products which are direct-acting antivirals containing a protease inhibitor for the treatment of hepatitis C virus infection, namely Maviret Tablets (containing glecaprevir/pibrentasvir; HK-65653), which is registered by Abbvie Limited; Zepatier Tablets (containing grazoprevir/elbasvir; HK-65571) and Zepatier Tablets (HK-66768), which are registered by Merck Sharp & Dohme (Asia) Ltd; Vosevi Tablets (containing sofosbuvir/velpatasvir/voxilaprevir; HK-65775), which is registered by Gilead Sciences Hong Kong Limited; and Sunvepra Capsules 100mg (containing asunaprevir; HK-64506), which is registered by Bristol-Myers Squibb Pharma (HK) Ltd. All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction related to glecaprevir/pibrentasvir (4 cases, of which one case is related to alanine aminotransferase increased and hyperbilirubinaemia), grazoprevir/elbasvir (one case, related to alanine aminotransferase increased) and asunaprevir (one case, related to alanine aminotransferase increased and bilirubin increased). The DH has not received any case of adverse drug reaction related to sofosbuvir/velpatasvir/voxilaprevir.
Related news on the risk of serious liver injury with the use of medicines containing a hepatitis C virus protease inhibitor in patients with advanced liver disease was previously issued by the United States Food and Drug Administration and Taiwan Food and Drug Administration, and was posted on the Drug Office website on 29 Aug 2019 and 9 Jul 2020. Letters to inform local healthcare professionals were issued by the DH on 29 Aug 2019. In light of the above Health Canada’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Dec 3, 2020
Issued at HKT 16:00
|
| |
|
