Long-term adefovir plus lamivudine therapy does not decrease creatinine clearance in HBeAg-negative chronic hepatitis B patients

Liver Int. 2011 Nov;31(10):1525-32. doi: 10.1111/j.1478-3231.2011.02616.x. Epub 2011 Aug 11.

Abstract

Background/aims: As there are concerns about potential nephrotoxicity of nucleotide analogues, we evaluated renal function parameters during long-term adefovir and lamivudine combination therapy.

Methods: Forty-six HBeAg-negative patients with lamivudine-resistance treated with adefovir and lamivudine for up to 90 months were included. Renal function was assessed by estimated creatinine clearance (eC(CR) ) and compared with a matched control group of untreated inactive hepatitis B virus carriers.

Results: Serum HBV DNA became undetectable in 39 (85%) patients after a mean of 37 ± 21 months. Three (6.5%) patients developed virological breakthrough. Adefovir resistance was detected in two patients. At the end of follow up, there was a significant decrease in mean eC(CR) (95 ± 31-83 ± 30 ml/min, P = 0.003) in the treated patients with 16% presenting aeC(CR) decrease >30%. Similar changes in eC(CR) were observed in the control group (108 ± 28-96 ± 26 ml/min, P = 0.003). In multiple regression analysis, age and baseline eC(CR) were independent predictors of eC(CR) reduction.

Conclusions: Adefovir and lamivudine combination therapy is not an independent factor for significant renal dysfunction in HBeAg-negative patients with lamivudine-resistance. Baseline age and creatinine clearance are the only independent predictors of worsening renal function.

Publication types

  • Clinical Trial

MeSH terms

  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Adult
  • Age Factors
  • Aged
  • Creatine / metabolism*
  • Drug Resistance, Viral / physiology
  • Drug Therapy, Combination
  • Female
  • Greece
  • Hepatitis B / drug therapy*
  • Hepatitis B e Antigens / blood
  • Humans
  • Kidney / metabolism*
  • Lamivudine / therapeutic use*
  • Linear Models
  • Male
  • Middle Aged
  • Organophosphonates / therapeutic use*

Substances

  • Hepatitis B e Antigens
  • Organophosphonates
  • Lamivudine
  • adefovir
  • Adenine
  • Creatine