FDA Warning: Direct-Acting Antivirals for Hepatitis C May Reactivate Hepatitis B

Agency revises drug labels

The FDA has issued a warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medications for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medications resulted in serious liver problems or death. HBV reactivation usually occurred within four to eight weeks.

As a result, the FDA is requiring a boxed warning about the risk of HBV reactivation to be added to the drug labels of these DAAs, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflets or medication guides for these medications.

The FDA compiled 24 cases of HBV reactivation from reports to the agency and from the published literature in HCV/HBV coinfected patients treated with DAAs during the 31 months from November 22, 2013, to July 18, 2016. Of the cases reported to the agency, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV coinfection were excluded from these studies.

According to the FDA, health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and should monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.

Source: FDA; October 4, 2016.