Efficacy of repeated high-dose hepatitis B vaccine (80 μg) in patients with chronic liver disease

Patients with chronic liver disease (CLD) respond poorly to standard hepatitis B (HBV) vaccine given as sequential 20 mu g IM shots because of an overall impaired immune response. Many of these patients go on to liver transplantation and are at risk of acquiring recurrent or de novo HBV infection. To evaluate the efficacy and safety of high-dose (80 mu g) IM HBV vaccination in patients with CLD who had previously failed to respond to a standard three-dose schedule of 40 mu g IM vaccine given monthly. A retrospective review was undertaken at our institution of 79 patients with CLD who were treated with high-dose (80 mu g) HBV vaccinations. All had previously failed a three-dose course of 40 mu g HBV vaccine. An HBV vaccine response was defined as an anti-HBs titer greater than 100 mIU/ml. Liver enzymes, creatinine, age, prothrombin time, total vaccine dose, and MELD score were recorded. No adverse events were reported. Seventy-two per cent (57/79) of the subjects had an adequate response after receiving a mean total dose of 220 mu g vaccine (range 80-800 mu g). Twenty-eight per cent (22/79) of the subjects did not respond after receiving a mean total dose of 420 mu g vaccine (range 240-720 mu g). Non-responders had more severe hepatic disease defined as a higher mean total bilirubin level (p = 0.003) and a lower mean albumin level (p < 0.05). Age, prothrombin time, MELD score, and creatinine were not statistically significant between the responders and non-responders. Repeated high-dose (80 mu g) HBV vaccination, in patients who do not respond to standard HBV vaccine doses, is safe and effective in the majority of patients with CLD.