Clinical effects of lamivudine combined with adefovir dipivoxil and entecavir alone in 48-week treatment of HBeAg-positive chronic hepatitis B: preliminary comparative study

ObjectiveTo compare treatment outcome, drug resistance rate, and safety between initial combination therapy with lamivudine (LAM) plus adefovir dipivoxil (ADV) and monotherapy with entecavir (ETV) in the treatment of HBeAg-positive chronic hepatitis B (CHB). MethodsFifty-six HBeAg-positive CHB patients, who received treatment in The First People′s Hospital of Foshan from May 2008 to February 2010, were divided into combination therapy group and monotherapy group using a random number table. The combination therapy group received LAM (100 mg/d) plus ADV (10 mg/d) once daily for 48 weeks, while the monotherapy group received ETV (0.5 mg/d) once daily for 48 weeks. The alanine aminotransferase (ALT) normalization rate, hepatitis B virus (HBV) DNA clearance rate, and HBeAg clearance rate were compared between the two groups by chi-square test. ResultsAfter 48 weeks of treatment, the ALT normalization rate showed no significant difference between the two groups (χ2=1.018, P＞0.05), but after 36 weeks of treatment, the ALT normalization rate was significantly higher in the monotherapy group than in the combination therapy group (χ2=4.082, P＜0.05). After 12 and 48 weeks of treatment, the HBV DNA clearance rate showed no significant difference between the two groups (χ2=1.167, P＞0.05; χ2=1.976, P＞0.05), but after 24 and 36 weeks of treatment, the HBV DNA clearance rate was significantly higher in the monotherapy group than in the combination therapy group (χ2=5.600, P＜0.05; χ2=9.164, P＜0.05). There was no significant difference in HBeAg clearance rate between the two groups. Over the course of treatment, neither group developed drug resistance, and the two therapies had good safety. ConclusionBoth initial combination therapy with LAM and ADV and monotherapy with ETV produce a good clinical effect in HBeAg-positive CHB patients after 48 weeks of treatment. ALT normalization and HBV DNA clearance occur earlier in patients receiving ETV alone than those receiving LAM plus ADV. The two therapies have good safety, cause little drug resistance, and produce good treatment outcome and hold promise for clinical application