Black-Box Warning Added to Hepatitis C Drugs

On Oct. 4, 2016, the Food and Drug Administration (FDA) released a warning that medications known as direct-acting antivirals (DAAs), which are used to treat hepatitis C, can reactivate the hepatitis B virus in patients with current or previous hepatitis B infections.[1] Examples of DAAs include sofosbuvir (SOVALDI), the fixed-dose combination of ledipasvir and sofosbuvir (HARVONI), and simeprevir (OLYSIO).

The FDA based its alert on cases, reported to the agency, of confirmed reactivation of hepatitis B virus in patients who were receiving treatment with DAAs for hepatitis C infection. Hepatitis B reactivation usually occurred four to eight weeks after the start of DAA treatment. Two patients died, and one required a liver transplant.

The agency has updated the product labels for all DAAs to carry a blackbox warning — the most serious warning the FDA can require — that explains this risk of hepatitis B reactivation.

Before starting a DAA, tell your doctor whether you have ever had hepatitis B or other liver problems. If you have had hepatitis B and start a DAA, your doctor should monitor you with blood tests to see whether the hepatitis B infection reactivates while you are taking a DAA, and for several months after you stop the medication.

After you start a DAA, tell your doctor immediately if you experience fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these might be signs of a serious liver problem related to hepatitis B reactivation. To see the FDA’s safety alert, visit the following webpage: http://www.fda.gov/ Drugs/DrugSafety/ucm522932.htm.

References

[1] FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. October 4, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm. Accessed May 18, 2017.