Conditions: Hepatitis B Liver Transplantation
Keywords: Vaccination Immunocompromised Host Antiviral Agents Drug Resistance, Viral Resource Allocation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.

Detailed description:
The investigators will conduct a prospective, open-label study of Hepatitis B naive patients who received HBcAb + livers and adefovir prophylaxis post-transplant. At one year to 18 months following transplantation, all study patients will then be vaccinated with standard Hepatitis B vaccine at double dose on a monthly basis for three months, at which point they will be tested for Hepatitis B surface antibody (HBsAb). Any study patients that have developed a sufficient antibody response (HBsAb \>500 IU) will be given the option to discontinue anti-viral treatment in a monitored setting.

Arms:
arm 1: Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose.

Interventions: intervention 1: Adefovir dipivoxil and hepatitis B vaccination
Intervention descriptions: intervention 1: Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Protocol document: