The FDA recently released a drug safety announcement concerning direct-acting antiviral medications used to treat chronic hepatitis C infection.
Here's what you need to know:
1. Patients who have a current or previous hepatitis B virus infection, and who are being treated with one of these medications (such as Daklinza, Epclusa or Harvoni, among others), are at risk of hepatitis B reactivation.
2. Some patients' whose hepatitis B infection had reactivated after hepatitis C treatment experienced serious liver problems — or even death.
3. The FDA has required their most prominent warning, a "boxed warning," about the risk of hepatitis B reactivation to be added to the drug labels of these hepatitis C medications.
4. The FDA says that healthcare professionals should screen and monitor all patients for current or previous hepatitis B infection prior to starting treatment with hepatitis C medication.
5. It is still unknown why the hepatitis B reactivation occurs.
