FOOD AND DRUG ADMINISTRATION WARNS OF HEPATITIS B REACTIVATION WITH HEPATITIS C DRUGS

October 7, 2016

Here’s an important alert for patients taking any of the medications known as direct-acting antivirals (DAAs) for hepatitis C. The medications in this group are:[1]

• daclatasvir (DAKLINZA)
• dasabuvir, ombitasvir, paritaprevir and ritonavir (VIEKIRA PAK)
• elbasvir and grazoprevir (ZEPATIER)
• ledipasvir and sofosbuvir (HARVONI)
• ombitasvir, paritaprevir and ritonavir (TECHNIVIE)
• simeprevir (OLYSIO)
• sofosbuvir (SOVALDI)
• sofosbuvir and velpatasvir (EPCLUSA)

On Oct. 4, the Food and Drug Administration (FDA) released a warning on the risk of DAAs reactivating the hepatitis B virus in patients with current or previous infection with hepatitis B.[2]

The FDA based its alert on 24 cases reported to the FDA or published in the medical literature from November 22, 2013, to July 18, 2016. The cases involved confirmed reactivation of hepatitis B virus in patients who were receiving treatment with DAAs for hepatitis C. The hepatitis B reactivation usually occurred four to eight weeks after starting DAA treatment.

At least 12 of the 24 cases received treatment for their reactivated hepatitis B infections, but in five of these cases, the treatment was delayed, and, in another three, it was possibly delayed. Two patients died, and one required a liver transplant.

The agency has updated the product labels for all DAAs to carry a black-box warning, the most prominent warning the FDA can require, of the risk of hepatitis B reactivation.

What You Can Do

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 on 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. To see the FDA’s safety alert, visit the following link: 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 October 5, 2016.

[2] Ibid.