OBJECTIVETo evaluate the efficacy and potential renal impairment of one-year combination therapy de novo of adefovir dipivoxil (ADV) and lamivudine (LMV) for decompensated cirrhosis related to HBV.

METHODSA total of 36 patients with decompensated cirrhosis related to HBV, nobody had nucleos(t)ide analogs (NAs) treatment history, were recruited and were divided into two group (control group and observation group) randomly. A monotherapy of LMV (100 mg per day) was selected to individuals in control group (n = 18), in contrast, a combination therapy de novo of ADV (10 mg per day) and LMV (100 mg per day) was applied to those in observation group (n = 18). Basic approaches including liver protection, symptom-driven intervention, and supporting therapy, were given to all of the individuals. A course of one year was applied to all. Liver function, Child-Pugh score, serum creatinine (sCr) level, virological response (VR) rate, and virological breakthrough rate were observed pro- and post- treatment, differences between the two populations were analysed statistically.

RESULTS(1) The averages of gender, age, HBeAg status, HBV viral load, sCr level, and Child-Pugh score were all compatible in the two groups at baseline (P > 0.05 for all). (2) At the endpoint of treatment, none of deaths was reported. Comparing with the status before treatment in each group itself, liver function, Child-Pugh score, and viral load were improved statistically (P < 0.01 for all), especially in observed group (P < 0.01 for all variables, vs control group), as for VR rate, result is significant superior to that of control group too (88.89% vs 66.67% , P < 0.05). (3) Virological breakthrough occurred to none in observed group and three cases (16.67%) in control group, all of them were confirmed to be rtM204V variant in the following detection of direct sequencing. (4) Elevated level of sCr didn't arised at the end of treatment in two groups.

CONCLUSIONPresent study reveals that in populations with decompensated cirrhosis related to HBV, one-year combination therapy de novo of ADV and LMV is superior to monotherapy of LMV, and the renal safety is favorable within one year.