Hepatitis B virus quasispecies evolution after liver transplantation in patients under long-term lamivudine prophylaxis with or without hepatitis B immune globulin.
Buti M, Tabernero D, et al.Transplant Infectious Disease. 2015 Apr; 17(2): 208-20
Aims
To investigate an optimal long-term prophylactic strategy for prevention of hepatitis B virus (HBV) recurrence after liver transplantation.
Interventions
Lamivudine (LAM) alone or combined with hepatitis B immune globulin (HBIg) as prophylaxis in patients who underwent orthotopic liver transplantation (OLT) for HBV -related complications.
Participants
Twenty-nine patients with HBV-associated liver disease undergoing OLT.
Outcomes
Liver function, HBsAg, hepatitis B e antigen (HBeAg), and HBV DNA.
Follow-up
10 years.
CET Conclusions
This paper reports the long-term results of a randomised controlled trial comparing long-term prophylaxis with lamivudine with or without hep B immunoglobulin in patients undergoing liver transplantation for hepatitis B. Clinical outcomes and recurrence of hepatitis B infection were similar between the two groups as far as 10 years post-transplant. This is a very small study (29 patients) and is probably not adequately powered to demonstrate a difference between the two strategies (no power calculation is presented in this or the original publication). Both appear reasonably effective, and outcomes were good. The authors demonstrate low transient HBV DNA levels (even in the absence of HBsAg), which provides some evidence in support of continued prophylaxis in these patients.
Data analysis
Per protocol analysis
Quality notes
Previously assessed as Buti, M., A. Mas, et al. Journal of Hepatology 38(6): 811-817. 2003.
Trial registration
Not reported.