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FDA Identifies Nine Direct-Acting Antivirals Linked to HBV Reactivation

The FDA has just released a list of nine direct-acting antivirals used to treat HCV that may lead to a reactivation of HBV in some individuals. Individuals who currently have HBV or have had HBV in the past are at risk for the virus returning while on these nine medications. The reactivation of the virus can become serious enough to lead to fatalities, according to the FDA.

The FDA has been investigating 24 cases of HBV reactivation between late 2013 and July 2016. Two of these cases resulted in death, and one resulted in a liver transplant. The nine HCV antivirals listed below are among the medications taken by these 24 individuals. The mechanism by which HBV gets reactivated in response to these antivirals hasn’t been uncovered, and was missed in clinical trials for the medications as most trials did not include participants with past or present HBV.

Boxed warnings on these medications will now be present, encouraging clinicians to screen individuals for past or current HBV infection before prescribing. It has been suggested that the reactivation risk can be reduced by undergoing treatment for HBV before or at the same time as the HCV antivirals are prescribed.

Other organizations such as the European Medicines Agency, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have all started analyzing this link, as well as updating guidelines for treatment of individuals with HCV who have a history of HBV. The mechanism between the medications and reactivation of HBV is currently being studied, with more information hopefully to come out soon!

Here are the nine antivirals the FDA has linked to HBV reactivation:

    1. Dalinza (Bristol-Myers Squibb): Active ingredient- Daclatasvir
    2. Epclusa (Gilead Sciences): Active ingredient- Sofosbuvir and velpatasvir
    3. Harvoni (Gilead Sciences): Active ingredient- Ledipasvir and sofosbuvir
    4. Olysio (Janssen): Active ingredient- Simeprevir
    5. Sovaldi (Gilead Sciences): Active ingredient- Sofosbuvir
    6. Technivie (AbbVie): Active ingredient- Ombitasvir, paritaprevir and ritonavir
    7. Viekira Pak (AbbVie): Active ingredient- Dasabuvir, ombitasvir, paritaprevir, ritonavir
    8. Viekira Pak XR (AbbVie): Active ingredient- Dasabuvir, ombitasvir, paritaprevir, ritonavir
    9. Zepatier (Merck Sharp Dohme): Active ingredient- eEbasvir and grazoprevir
    1. “HCV Drugs May Reactivate HBV, FDA Warns.” Medscape. Oct 4 2016. Available from: