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

Columbia University16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B Liver Transplantation

Interventions

Adefovir dipivoxil and hepatitis B vaccinationDRUG

Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Liver Disease and Transplantation at Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver

Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (\>40 IU/mL).

Time frame: Standard of care visits post-transplant for 2 years

Secondary Outcomes

Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination

Time frame: 12-18 months post transplant

Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal

Time frame: Six months after hepatitis B vaccination (2 years post transplant)

Data from ClinicalTrials.gov

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