Prophylaxis of HBV reinfection and disease in liver transplanted patients: 2024 update on the role of HBIG and cost-effectiveness evaluation

Hepatitis B virus (HBV) infection is a major global health concern, with liver transplantation (LT) serving as a critical treatment for end-stage liver disease caused by HBV. However, the risk of HBV reinfection after LT remains significant, necessitating effective prophylaxis. Today, the combination of hepatitis B immune globulin (HBIG) and high-barrier nucleos(t)ide analogues (NUCs) is the standard of care for preventing HBV recurrence post-LT but concerns about the cost of HBIG and access to high-barrier NUCs have led to a reduction in the use, dose, and duration of HBIG in recent years. This review provides an updated analysis of the role of HBIG in preventing HBV recurrence post-LT, alongside a detailed evaluation of its cost-effectiveness, leveraging recent pharmacoeconomic data from Italy. The cost analysis showed that HBIG contributes approximately 12.4% (€ 49,000) to the total lifetime cost of LT-related healthcare (€395,986). Short-term HBIG prophylaxis reduced costs by 11.1%, while lifetime usage increased total costs by only 6.6%. However, the primary cost drivers were renal failure and immunosuppressive therapy. In conclusion, despite advancements in NUCs therapy, HBIG remains a cornerstone of HBV prophylaxis post-LT, particularly in high-risk patients, and discontinuation of HBIG in favor of alternative prophylaxis strategies lacks robust supporting evidence. Tailoring prophylaxis to individual patient needs and risk factors allows for personalized treatment while maintaining efficacy.