The United States: The United States: FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C (English Only)

The United States: FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C (English Only)
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, FDA is requiring a Boxed Warning, the 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. 

DAA 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. A list of US-approved DAA can be found at the FDA website. 

FDA identified 24 cases of HBV reactivation reported to FDA 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. This number includes only cases submitted to FDA, so there are likely additional cases about which FDA is 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. 

Health care professionals are advised to 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 are advised to tell their health care professional if they have a history of hepatitis B infection or other liver problems before being treated for hepatitis C. Do not stop taking their DAA medicine without first talking to health care professional, as stopping treatment early could result in their virus becoming less responsive to certain hepatitis C medicines. Contact their health care professional immediately if they 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. 

Please refer to the following website in FDA for details: 

In Hong Kong, there are four registered pharmaceutical products which are DAA medicines, namely Harvoni Tablets [sofosbuvir/ ledipasvir (HK-63886)] and Sovaldi Tablets 400mg [sofosbuvir (HK-63501)] which are registered by Gilead Sciences Hong Kong Limited, Viekira Pak Tablets [ombitasvir/ paritaprevir/ ritonavir/ dasabuvir (HK-63695)] which is registered by Abbvie Limited, and Daklinza Tablets 60mg [daclatasvir (HK-64505)] which is registered by Bristol-Myers Squibb Pharma (HK) Ltd. All these products are prescription only medicines. There is no registered pharmaceutical product containing simeprevir, velpatasvir, elbasvir or grazoprevir. Related news on review to assess the extent of HBV reactivation and risk of liver cancer in patients treating with DAA was issued by the EMA, and was posted on the Drug Office website on 21 March and 18 April 2016. The letter to healthcare professionals to draw their attention on the EMA review was issued on 18 April 2016. So far, the Department of Health (DH) has not received any adverse drug reaction report of HBV reactivation in connection with any DAA medicines. In view of the addition of Boxed Warning by FDA, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee). DH will remain vigilant on the conclusion of the EMA review and the information will also be forwarded to the Committee for consideration. 

Ends/ Wednesday, October 05, 2016 
Issued at HKT 14:30