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

Columbia University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Transplantation; Hepatitis B

Treatments: Drug: Adefovir dipivoxil and hepatitis B vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01146808

AAAB8413

IN-US-103-0158 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

ADV plus hepatitis B vaccination

Experimental group

Description:

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.

Treatment:

Drug: Adefovir dipivoxil and hepatitis B vaccination