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A novel experience of antiviral therapy for chronic hepatitis B in renal transplant recipients.

AbstractBACKGROUND:
Entecavir (ETV) is a potent inhibitor of viral replication in chronic hepatitis B. There is no published data concerning ETV therapy in nucleoside analogue (NUC)-naive hepatitis B surface antigen (HBsAg)-positive renal transplant recipients (RTRs).
METHODS:
We prospectively treated 27 HBsAg-positive RTRs with ETV since 2007. Serial HBV DNA was assessed at baseline and weeks 12, 24, 52 and 104 after treatment. A cohort of 19 patients who received 2-year lamivudine (3TC) therapy during 2004-2007 was used as a historical control.
RESULTS:
Of the 27 RTRs, 18 (67%) were NUC-naive patients and 9 (33%) were 3TC-experienced without YMDD mutations. HBV DNA levels became undetectable in 70%, 74%, 96% and 100% of patients after 12, 24, 52 and 104 weeks, respectively, of ETV treatment without viral resistance. There was no change of glomerular filtration rate, and no lactic acidosis or myopathy during treatment. By comparison with the 19 3TC-treated patients, ETV-treated RTRs presented higher rates of undetectable HBV DNA than 3TC-treated RTRs (32%, 37%, 63% and 63% at 12, 24, 52 and 104 weeks; P<0.005). In an analysis excluding 9 patients from the ETV group who were also 3TC-experienced, the remaining 18 ETV-naive RTRs exhibited a better virological response at 52 and 104 weeks than 19 3TC-treated RTRs (P<0.05). Even in the 9 patients who overlapped in two cohorts, ETV exhibited a more rapid virological response than 3TC did, especially at 12 and 24 weeks (P=0.009).
CONCLUSIONS:
ETV is effective in treating chronic hepatitis B in RTRs. ETV is safe with regards to renal graft function, lactic acidosis, myopathy and virological resistance.
AuthorsTsung-Hui Hu, Ming-Chao Tsai, Yu-Shu Chien, Yen-Ta Chen, Te-Chuan Chen, Ming-Tzung Lin, Kuo-Chin Chang, King-Wah Chiu
JournalAntiviral therapy (Antivir Ther) Vol. 17 Issue 4 Pg. 745-53 ( 2012) ISSN: 2040-2058 [Electronic] England
PMID22522918 (Publication Type: Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Lamivudine
  • entecavir
  • Guanine
Topics
  • Adult
  • Aged
  • Antiviral Agents (administration & dosage, therapeutic use)
  • DNA, Viral (blood)
  • Female
  • Guanine (administration & dosage, analogs & derivatives, therapeutic use)
  • Hepatitis B Surface Antigens
  • Hepatitis B, Chronic (drug therapy)
  • Humans
  • Kidney Transplantation (adverse effects)
  • Lamivudine (administration & dosage, therapeutic use)
  • Male
  • Middle Aged

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