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FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

The U.S. Food and Drug Administration (FDA) is 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) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death.

As a result, we are requiring a Boxed Warning, our most prominent 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 leaflet or Medication Guides for these medicines.

Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death (see List of Direct-Acting Antivirals).

Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up. It is currently unknown why the reactivation occurs.

Patients should tell your health care professional if you have a history of hepatitis B infection or other liver problems before being treated for hepatitis C. Do not stop taking your DAA medicine without first talking to your health care professional. Stopping treatment early could result in your virus becoming less responsive to certain hepatitis C medicines. Read the patient information leaflet or Medication Guide that comes with each new prescription because the information may have changed. Contact your health care professional immediately if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of serious liver problems.

We identified 24 cases of HBV reactivation reported to FDA1 and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016.2-7 This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware. Of the cases reported, 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 co-infection were excluded from the trials. The trials excluded these patients in order to specifically evaluate the safety of DAAs, including their effects on the liver, in patients infected with only HCV and without the presence of another virus which affects the liver (see Data Summary).

We urge health care professionals and patients to report side effects involving DAAs and other medicines to the FDA MedWatch program.

List of Direct-Acting Antivirals (DAAs)*


Brand name

Active ingredient(s)

Drug Manufacturer

Daklinza

daclatasvir

Bristol-Myers Squibb

Epclusa

sofosbuvir and velpatasvir

Gilead Sciences

Harvoni

ledipasvir and sofosbuvir

Gilead Sciences

Olysio

simeprevir

Janssen

Sovaldi

sofosbuvir

Gilead Sciences

Technivie

ombitasvir and paritaprevir and ritonavir

Abbvie

Viekira Pak

dasabuvir and ombitasvir and paritaprevir and ritonavir

Abbvie

Viekira Pak XR

dasabuvir and ombitasvir and paritaprevir and ritonavir

Abbvie

Zepatier

elbasvir and grazoprevir

Merck Sharp Dohme

*DAA regimens not requiring use in combination with interferon. The DAA medicines, Victrelis (boceprevir) and Incivek (telaprevir), are not included in the list as they are used in combination with interferon and are no longer available in the United States.

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