Direct-acting antiviral interferon-free regimens to treat chronic hepatitis C: risk of hepatitis B reactivation

All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens. Patients who are co-infected with hepatitis B and C viruses are at risk of hepatitis B reactivation, and should be monitored and managed according to current clinical guidelines.

Advice for healthcare professionals:

  • rapid reduction in hepatitis C viral load during treatment with direct-acting antiviral interferon-free regimens may lead to increased replication of hepatitis B virus in co-infected patients
  • all patients with hepatitis C who are starting therapy with direct-acting antiviral interferon-free regimens should be screened for hepatitis B infection, and should be monitored and managed for co-infection according to current clinical guidelines

Advice for professionals to give to patients:

  • patients should be advised to inform their doctor or pharmacist if they have a current or previous infection with hepatitis B virus if they are prescribed direct-acting antiviral interferon-free regimens for hepatitis C
  • patients should be advised that they may be monitored more closely if they have a current or previous infection with hepatitis B virus

Direct-acting antivirals used as part of interferon-free regimens for the treatment of chronic hepatitis C infection are: daclatasvir (Daklinza▼); dasabuvir (Exviera▼); ombitasvir, paritaprevir, ritonavir (Viekirax▼); sofosbuvir (Sovaldi▼); ledipasvir with sofosbuvir (Harvoni▼); and simeprevir (Olysio▼).

Cases of a return of previously inactive hepatitis B infection have been reported in patients treated with direct-acting antiviral interferon-free regimens who were infected with hepatitis B and C viruses. An EU-wide review has confirmed that there is a risk of hepatitis B reactivation in patients co-infected with hepatitis B and C viruses who are initiated on these antivirals for chronic hepatitis C.

The benefits of treatment with direct-acting antiviral interferon-free regimens for chronic hepatitis C continue to outweigh the risks of reactivation of hepatitis B infection. However, all patients should be screened for hepatitis B before initiation of treatment with hepatitis C direct-acting antiviral interferon-free regimens. Co-infected patients should be monitored and managed according to current clinical guidelines.

Any suspected adverse reactions to direct-acting antivirals should be reported to us on a Yellow Card.

Article citation: Drug Safety Update volume 10 issue 6, January 2017: 1.

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