Hepatitis B or Delta liver transplant patients at risk of recurrence: Long-term effectiveness and budget impact of low-dose subcutaneous anti-hepatitis B immunoglobulin plus patient education program

Intravenous (IV) hepatitis B immunoglobulin (HBIg) following liver transplantation reduces graft loss attributable to hepatitis B and D virus (HBV, HDV) recurrence. At-risk patients still require long-term HBIg treatment, which is inconvenient and costly. We investigated the long-term feasibility of switching to tailored, low dose, self-administered subcutaneous (SC) HBIg in high-risk patients stabilized on IV HBIg plus nucleotide analog therapy. Patients with liver transplantation and at high risk of HBV recurrence were enrolled in a patient education program (PEP). Treatment with SC HBIg 500 IU every 15 days was started 1 month after the last dose of IV HBIg. Injections were administered by patients at home following instruction. Dosage was tailored to maintain HB surface antibody levels >50 or 100 IU/L, depending on risk profile. Patients’ skills acquisition, satisfaction and adherence were assessed. HB surface antigen, HBV DNA and alanine aminotransferase were monitored regularly. Budget impact was assessed by comparing the direct costs of 3 years’ treatment with IV versus SC HBIg for each patient. Ten patients were prospectively enrolled. Mean time since transplantation was 6.8 years. By year 3, no cases of HBV recurrence and no treatment-related adverse events occurred. The PEP was associated with high levels of skills acquisition, satisfaction, and adherence to treatment. Switching from IV to SC HBIg led to a 56% reduction in annual direct costs per patient. Trained, high-risk patients receiving IV HBIg can successfully and satisfactorily switch to long-term self-administered SC HBIg treatment, markedly reducing direct costs.