A randomized trial of emtricitabine/tenofovir disoproxil fumarate after hepatitis B immunoglobulin withdrawal post-liver transplant.
Teperman LW, Poordad F, et al.Liver Transplantation 2013; 19(6):594-601
Aims
To assess whether hepatitis B immunoglobulin (HBIG) withdrawal after the addition of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) results in the recurrence of HBV in patients previously maintained on HBIG alone.
Interventions
Patients were randomized to receive FTC/TDF without HBIG or FTC/TDF plus HBIG. Patients received immunosuppressant regimes per institution-specific guidelines.
Participants
37 adults 18-75 years old with chronic hepatitis B virus [either hepatitis B e antigen (HBeAg)-positive or HBeAg-negative] before orthotopic liver transplantation
Outcomes
Primary outcomes included: recurrence of chronic HBV viremia defined as a confirmed HBV DNA level ≥ 400 copies/mL at 2 consecutive visits before week 72, or an HBV DNA level ≥ 400 copies/mL at the week 72 visit while the patient was on randomized treatment. Secondary outcome measures included: HBV recurrence defined as 2 consecutive visits with an HBV DNA level ≥ copies/mL up to week 96, the proportion of patients with an HBV DNA level < 169 copies/mL by visit, the alanine aminotransferase value and the mean change from the study outcome visit.
Follow-up
96 weeks.
CET Conclusions
In this small phase two study patients with hepatitis B virus with chronic infection were treated with FTC and TDF plus hepatitis B immunoglobulin following liver transplantation for 24 weeks and then were randomised either to continue the combined treatment or just to continue the drug treatment. The first phase of the study lasted 72 weeks and at the end of that time no patients had hepatitis B virus recurrence. Thus withdrawal of HBIG after 6 months treatment with FTC/TDF should be considered in liver transplant recipients to prevent chronic HBV recurrence. A larger study is required and possibly HBIG could be withdrawn earlier than 6 months.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT00507689