Dive Brief:
- The Food and Drug Administration on Monday saidt is requiring a boxed warning on the label of direct-acting antiviral (DAA) hepatitis C treatments, after more than two dozen reports of serious hepatitis B reactivation in patients who had both infections.
- Two deaths and a serious liver problem that required a transplant occurred in patients being treated with hepatitis C medications. The hepatitis B reaction could recur within four to eight weeks and patients should be monitored and screened.
- The agency’s most serious warning will now be included on the label for nine of the most highly-visible DAAs, including the blockbuster hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) from Gilead, as well as the Viekira Pak marketed by AbbVie. The warning will also be included in the patient information leaflet or Medication Guides for these medicines.
Dive Insight:
The FDA has identified 24 cases of hepatitis B reactivation from patients and published literature, within 31 months, with two patients dying and one requiring a liver transplant. The numbers include only cases reported to the FDA said the alert, which warns that "there are likely additional cases about which FDA is unaware." The identified cases occurred between Nov. 22, 2013 and July 18, 2016.
The adverse event of hepatitis B was not previously reported during clinical trials because patients who were co-infected with hepatits B were not included in those studies so that companies could adequately test the affect of the drug on hepatitis C without interference from other liver infections.
The FDA agency is using its most prominent warning about the risk of hepatitis B reactivation to be added to the drug labels of DAAs, directing healthcare professionals to screen and monitor for hepatitis B in patients receiving DAA treatment.
Around the world, other healthcare regulators, including the European Medicines Agency (EMA), have begun investigations into DAAs.
The DAA medications have been used to treat the chronic hepatitis C virus infection. An estimated 2.7 to 3.9 million people in the U.S. are infected with chronic hepatitis C, according to the Centers for Disease Control and Prevention. Hepatitis B affects between 850,000 and 2.2 million residents, the CDC said.