ZUTECTRA (Human hepatitis B immunoglobulin) - Prevention of hepatitis B

Opinions on drugs - Posted on May 15 2025

Reason for request

Modification of the listing conditions

Summary of opinion

Favourable opinion for reimbursement in the following indication “Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B-induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start.”

Clinical Benefit

Substantial

That the clinical benefit of ZUTECTRA 500 UI is substantial in the MA indication.

Clinical Added Value

minor

Considering:

demonstration of the absence of failure to ZUTECTRA treatment, the primary endpoint, in all the patients enrolled and treated in the ZEUS study,
a safety profile deemed to be favourable,

and despite:

the non-comparative design of the study,
limited experience, with a follow-up period of 24 weeks,

The Committee deems that updating of the treatment regimen for ZUTECTRA 500 IU does not modify the minor clinical added value (CAV IV) according to the previous opinion (Transparency Committee opinion of 16/11/2011) in the current care pathway for prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B-induced liver failure.