Studies on effect of adefovir dipivoxil monotherapy or combination therapy with lamivudine for patients with lamivudine-resistant chronic hepatitis B

Objective To evaluate the efficacy and safety of adefovir dipivoxil(ADV) monotherapy and ADV lamivudine(LAM) combined therapy for patients with LAM-resistant chronic hepatitis B.Methods 124 chronic hepatitis B patients with LAM-resistant mutations were enrolled in the present study.74 patients were treated with ADV combined with LAM therapy,and other 50 patients subjected to ADV monotherapy.There were no differences between the two groups in patients' baseline characteristics.Sequencing of the HBV polymerase gene was performed to determine LAM and ADV mutations occurred at baseline or during therapy.All patients were monitored with clinical examinations and routine laboratory tests during the therapy.Results The reduced logarithmic values of serum HBV DNA after 12-week and 24-week treatment were 1.99±0.64 and 2.61±0.80 in ADV group,obviously lower compared with those in ADV+LAM group(2.55±0.74 and 3.19±0.82,respectively,P0.01).The virological response rate after 12-week and 24-week treatment decreased in ADV group compared with those in ADV+LAM group(52.0% vs 78.4%,P0.01;78.0% vs 91.9%,P0.05).After 24-week treatment with ADV,the HBV DNA level in serum became undetectable in 70.3% of patients in ADV+LAM group,significantly higher than in patients of ADV group which was 48.0%(P0.05).When the treatment continued to 48 week,no ADV-resistant was found in all 43 patients in ADV+LAM group,whereas it was 14.8%(4/27) in patients with ADV monotherapy(P0.05).Conclusions ADV and LAM combination therapy may lead to better virological outcome in patients compared with ADV monotherapy.ADV and LAM combination therapy may be the first-choice for patients with LAM resistance.