FDA Issues Warning for HCV/HBV Co-infected Patients on Certain HCV Drugs

Boxed Warning to be added to the drug labels
Boxed Warning to be added to the drug labels

The Food and Drug Administration (FDA) has issued a warning regarding the risk of hepatitis B virus (HBV) reactivating in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) drugs for hepatitis C virus (HCV). HBV reactivation was typically seen within 4–8 weeks. 

DAAs, indicated to treat HCV infection, work by reducing the amount of virus in the body by preventing HCV from multiplying and in most cases, cure HCV. A total of 24 cases of HBV reactivation among HCV/HBV co-infected patients treated with DAAs were reported to the FDA and/or published in literature between November 22, 2013–July 18, 2016. Of the total cases reported, two patients died and one required a liver transplant. These cases were reported in HCV patients who were hepatitis B surface antigen (HBsAg) positive and also in patients with serologic evidence of resolved HBV infection (eg, HBsAg negative, anti-HBc positive), and were not receiving HBV antivirals. This risk has been seen with DAAs used without interferon for HCV treatment. 

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Currently approved DAAs include:

  • Daklinza (daclatasvir)
  • Epclusa (sofosbuvir, velpatasvir)
  • Harvoni (ledipasvir)
  • Olysio (simeprevir)
  • Sovaldi (sofosbuvir)
  • Technivie (ombitasvir, paritaprevir, ritonavir)
  • Viekira Pak/Viekira Pak XR (dasabuvir, ombitasvir, paritaprevir, ritonavir)
  • Zepatier (elbasvir, grazoprevir)

The FDA is mandating a Boxed Warning about the risk of HBV reactivation to be added to the drug labels of these DAAs. Healthcare professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs by measuring HBsAg and anti-HBc; patients with serologic evidence of HBV should have their baseline HBV DNA measured prior to treatment. Patients should be monitored using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up. 

For more information visit FDA.gov.

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