FDA: Risk Tied to Some Antiviral Medications

Hepatitis C antiviral medications may reactivate hepatitis B

(RxWiki News) The US Food and Drug Administration (FDA) has issued a warning about the potential for hepatitis B virus (HBV) reactivation with the use of certain antivirals.

The warning is for direct-acting antivirals used to treat hepatitis C virus (HCV). These antivirals include Daklinza (daclatasvir), Epclusa (sofosbuvir and velpatasvir), Harvoni (ledipasvir and sofosbuvir), Olysio (simeprevir), Sovaldi (sofosbuvir), Technivie (ombitasvir and paritaprevir and ritonavir), Viekira Pak and Viekira Pak XR (dasabuvir and ombitasvir and paritaprevir and ritonavir) and Zepatier (elbasvir and grazoprevir).

This warning is being issued because there is a risk of HBV becoming an active infection in those who have a current or previous infection with HBV and who are treated with a direct-acting antiviral to treat HCV .

As a result, the FDA is requiring these medications to include a boxed warning — the FDA's most prominent warning.

This warning also directs health care providers to screen and monitor for HBV in patients taking a direct-acting antiviral.

Tell your health care provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.

The FDA also recommends that patients do not stop taking medicine without speaking with their doctor. In some cases, stopping your medication can make it more difficult to treat your condition.

It is also important to tell your health care provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite or light-colored stools. These may be signs of a serious liver problem.