Efficacy and safety of telbivudine alone and combined with adefovir for the treatment of nucleos(t)ide-naive chronic hepatitis B in patients with high-level hepatitis B virus load / 中华肝脏病杂志

ABSTRACT

<p><b>OBJECTIVE</b>To compare the efficacy of telbivudine monotherapy and telbivudine combination therapy with adefovir in patients with nucleos(t)ide-naive chronic hepatitis B, high-level hepatitis B virus (HBV) load and hepatitis B e antigen (HBeAg)-positivity, and to explore the relationship between treatment regimen adherence and treatment outcomes.</p><p><b>METODS</b>A retrospective study was performed with 123 HBeAg-positive, high-level viral load (HBV DNA≥10(7) copies/ml), nucleos(t)ide-naive chronic hepatitis B patients. Fifty-three of the patients received combination therapy with telbivudine and adefovir dipivoxil,while 70 patients received the telbivudine monotherapy. All patients were tested for rates of conversion to HBV DNA-negative status,alanine aminotransferase (ALT) normalization, HBeAg seroconversion, drug resistance, and side effects at treatment weeks 12, 24, and 48. Treatment regimen adherence was assessed through self-reporting, and interviews were used to explore the relationships to treatment outcomes. The chisquare test, t test and Fisher's exact test were used for statistical analyses.</p><p><b>RESULTS</b>The rates of HBV DNA negative conversion in the combination group at treatment weeks 12, 24 and 48 were 62.3% (33/53), 88.7% (47/53) and 94.3% (50/53) and were significantly different from those in the monotherapy group at weeks 12 and 24.The rates of ALT normalization were significantly different between the two groups at treatment week 12 (94.3% vs. 77.1%). The rate of HBeAg seroconversion in the combination group at treatment week 48 was 39.6%, and significantly different than that of the monotherapy group. The rates of drug-resistance in the combination and monotherapy groups at treatment week 48 were 3.8% and 11.4%, and the proportion of non-adherence to the treatment regimen was 53.3%, which significantly affected treatment outcome. No side effects occurred in either treatment group.</p><p><b>CONCLUSION</b>Telbivudine combination treatment with adefovir was more effective than telbivudine monotherapy and elicited a low drug resistance rate in nucleos(t)idenaive chronic hepatitis B patients with high-level HBV load and HBeAg-positivity. Adherence to the therapy regimen was a key factor influencing treatment outcomes.</p>