Nucleoside plus nucleotide analogs and cessation of hepatitis B immunoglobulin after liver transplantation in chronic hepatitis B is safe and effective

Abstract

Background: After orthotopic liver transplantation (OLT) in chronic hepatitis B (HBV), adequate prophylaxis for recurrence of HBV in the graft is mandatory.

Objectives: Evaluate safety of HBV prophylaxis with tenofovir and emtricitabine (TDF/FTC) after cessation of hepatitis B immunoglobulin (HBIG) after OLT in chronic HBV.

Study design: In 17 consecutive patients after OLT in chronic HBV we started TDF/FTC after cessation of HBIG. All had received HBIG >6 months. 15/17 were HBsAg negative and 16/17 had undetectable HBV-DNA.

Results: After mean follow-up of 2 years 16/17 patients were alive, one died due to urosepsis. All 16 with undetectable HBV-DNA remained HBV-DNA negative. From 15 HBsAg negative patients at start, in one seroconversion to positive HBsAg occurred, without detectable HBV-DNA. Liver biochemistry remained within the normal ranges. There were no cases of drug discontinuation. No major side effects were reported. TDF/FTC use saves €16,262/year over standard-of-care (HBIG+LAM). This prospective follow-up study shows that in liver transplantation for chronic hepatitis B, after initial treatment including HBIG for at least 6 months combined with or followed by (dual) nucleos(t)ide analog therapy, TDF/FTC provides adequate prophylaxis against recurrent HBV infection without major side effects and leads to substantial cost savings over a regimen with HBIG.

Conclusion: Combined prophylaxis with TDF/ETV nucleoside plus nucleotide analogs and cessation of immunoglobulin after liver transplantation in chronic hepatitis B is safe and effective.

Keywords: ADV; ALT; AST; ETV; Emtricitabine; FTC; GFR; HBIG; HBV; HBeAg; HBsAg; HCV; HDV; HIV; Hepatitis B; IU; Immunoglobulin; LAM; LAMr; Liver transplantation; MDRD; OLT; Prevention; TDF; TDF/FTC; Tenofovir; adefovir; alanine aminotransferase; anti-HBe; anti-HBs; aspartate aminotransferase; emtricitabine; entecavir; glomerular filtration rate; hepatitis B e antibody; hepatitis B e antigen; hepatitis B immunoglobulin; hepatitis B surface antibody; hepatitis B surface antigen; hepatitis B virus; hepatitis C virus; hepatitis delta virus; human immunodeficiency virus; international units; lamivudine; lamivudine resistance; modification of diet in renal disease; orthotopic liver transplantation; tenofovir; tenofovir and emtricitabine.