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# Warning Added on Hep C Drugs about Hep B Infections
- URL: https://www.fdaweb.com/warning-added-on-hep-c-drugs-about-hep-b-infections/
- Published: 2016-10-04T12:00:00.000Z
- Updated: 2026-09-14T21:36:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136980

FDA has warned patients and healthcare providers 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 (see listing below). In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death, a new [safety alert](http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says. As a result, a Boxed Warning has been ordered for DAAs that directs healthcare professionals to screen and monitor for HBV in all patients receiving such treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.

FDA says it identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs since 2013\. “This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware,” the alert says. “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.”

List of DAAs:

- Bristol-Myers Squibb’s Daklinza (daclatasvir)
- Gilead Sciences’ Epclusa (sofosbuvir and velpatasvir)
- Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir)
- Janssen’s Olysio (simeprevir)
- Gilead Sciences’ Sovaldi (sofosbuvir)
- Abbvie’ Technivie (ombitasvir and paritaprevir and ritonavir)
- Abbvie’s Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir)
- Abbvie’s Viekira Pak XR (dasabuvir and ombitasvir and paritaprevir and ritonavir)
- Merck’s Zepatier (elbasvir and grazoprevir)