Review of liver cancer risk not conclusive and further studies are needed
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that patients treated with medicines known as direct-acting antivirals for hepatitis C may be at risk of hepatitis B re-activation. As a result of this review, the PRAC has recommended that, before starting treatment, all patients should be screened for hepatitis B virus; those patients co-infected with hepatitis B and C viruses must then be monitored and managed according to current clinical guidelines.
Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are important medicines for the treatment of chronic (long term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Cases of the return of previously inactive hepatitis B infection (re-activation), which can be fatal, have been reported in patients treated with direct-acting antivirals who were infected with hepatitis B and C viruses. This is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus, which is known to suppress the hepatitis B virus, and the lack of activity against hepatitis B virus of direct-acting antivirals.
Although the frequency of hepatitis B re-activation appears low,2 the PRACrecommended that a warning be included in the prescribing information for these medicines.
The PRAC also reviewed the available data on liver cancer (hepatocellular carcinoma) in patients treated with direct-acting antivirals and concluded that further studies should be carried out before firm conclusions can be drawn. The Committee will continuously review any other new data as they become available.
The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of the Agency’s final opinion. Further detailed advice for patients and healthcare professionals will be published at the time of the CHMP opinion.