Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

Prevention of de Novo Hepatitis B Infection With Adefovir Dipivoxil (ADV) and Hepatitis B Vaccination in HBsAg Seronegative Recipients of Liver Grafts From Hepatitis B Core Antibody Positive (HBcAb+) Donors

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.

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.

Inclusion Criteria:

• Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:

  1. received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts,
  2. received adefovir treatment post transplantation, and
  3. who have not reached the 18 month post transplantation time period.

Exclusion Criteria:

• Recipients with hepatitis B surface antigen positivity prior to liver transplant.
• Grafts from hepatitis B surface antigen positive patients.
• Previous intolerance to ADV therapy
• Recipients with pre-transplant creatinine > 1.6 mg/dL
• Patients younger than 21 years of age
• Patients who are pregnant or breastfeeding