Drug Safety Regulators Flag An Increased Risk Of Hepatitis B Virus Reactivation Which Can Result In Cases Of Fulminant Hepatitis, Liver Failure, And Death
(Posted by Tom Lamb at DrugInjuryWatch.com)
In February 2017 a so-called "black-box" warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases of hepatitis B virus (HBV) reactivation have been reported. Further, it states that some of those cases resulted in fulminant hepatitis, hepatic failure, and death.
You can view the Prescribing Information for Sovaldi (accessed 2/16/17) to see how this new black-box, or bolded, warning appears on the drug label.
For more details, we get the following from the Warnings and Precautions part of the February 2017 revised Sovaldi drug label:
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.
HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.
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Here is some background about this new drug safety development:
- In April 2016 we posted this article, "European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New "Hep-C" Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation"; and,
- In October 2016 we posted this article, "Harvoni, Sovaldi, Viekira Pak, And Other Direct-Acting Antivirals Get Black-Box Warning: Risk Of Hepatitis B Virus Reactivation".
More recently, on December 1, 2016 Health Canada issued this document, "Summary Safety Review -- Direct-acting antivirals -- Assessing the Potential Risk of Hepatitis B Virus Reactivation", from which we get the following information:
- Direct-acting antivirals (DAAs) are drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection, a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) and liver cancer.
- Health Canada carried out a review of the potential risk of hepatitis B virus (HBV) reactivation with the use of DAAs. The review was triggered by reports that patients infected with both HBV and HCV may experience a reactivation of their HBV infection if DAAs are used to treat their HCV infection. These reports were identified by the European Medicines Agency (EMA).
- Health Canada's review concluded that there is a potential risk of HBV reactivation in patients coinfected with both HBV and HCV, and the use of DAAs. Health Canada has recommended that the safety information for all DAAs be updated to inform about this potential risk.
We will continue to monitor this aspect of the safety profile of Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals (DAAs) used increasingly in the US and elsewhere to treat the hepatitis C virus (HCV).
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