Bulevirtide (Hepcludex)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Hepcludex should be reimbursed by public drug plans for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease if certain conditions are met.
• Hepcludex should only be covered to treat adult patients with compensated liver disease and confirmed chronic HDV infection, evidenced by a positive serum anti-HDV antibody result and detectable HDV ribonucleic acid (RNA) by polymerase chain reaction (PCR) within the past 6 months. These patients must also have elevated liver enzymes (alanine aminotransferase [ALT] levels between 1 and 10 times the upper limit of normal) and a blood albumin level greater than 2.8 mg/L. Patients who do not meet the eligibility criteria include those with decompensated liver disease or a total bilirubin level of 34.2 μmol/L or higher.
• Hepcludex should only be reimbursed if the patient is under the care of a hepatologist or infectious disease specialist with experience in the treatment of viral hepatitis and if the cost of Hepcludex is reduced. To continue receiving Hepcludex, a patient’s HDV infection must respond to treatment within the first 48 weeks. This means the HDV RNA level is no longer detectable in the blood or has dropped by at least 100 times compared to the start of treatment. After this, the need for ongoing treatment should be checked every 48 weeks. The patient’s liver enzyme levels should continue to be monitored by a specialist. Hepcludex should not be reimbursed for patients when used concurrently with pegylated interferon (PEG-IFN) therapy for chronic HDV infection.