| OBJECTIVE To evaluate the efficacy and safety of Adefovir dipivoxil (ADV) on treatment of Hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B.METHODS Patients who meets the criteria were randomized to adefovir dipivoxil group (Group A), or control group (Group B) with a 1:1 randomization. Male and female patients 18 to 65 years of age who had hepatitis B e antigen - positive chronic hepatitis B and compensated liver disease were eligible for the study. Chronic hepatitis B was defined by the presence of serum hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) for at least 6 months, a serum HBV DNA level ≥ 1.0×10~6 (evaluated using real-time fluorogenetic quantitative PCR), and alanine aminotransferase (ALT) level between 2-10 upper limit of normal (ULN) for at least on times within 6 months before screening and ALT > 1 ULN at screening. Women of childbearing potential were eligible if they had a negative pregnancy test; all patients must sign the informed consent. Criteria for exclusion included a coexisting of hypercellular carcinoma, decompensated liver diseases,renal diseases, anemia, autoimmune hepatitis, other serious medical illness that was not due to hepatitis B, seropositivity for human immunodeficiency virus (HIV) or hepatitis C or D virus, immune-or cytokine-based therapies such as immunosuppressants, immunomodulators or antiviral drugs with within 6 months before screening, any renal toxicity therapies within 2 months before screening, be irritability to nucleoside or nucleotide analogue. The treatment period was 48 weeks. During the first 12 weeks of the trial, patients in group A received 10 mg of ADV once a day while patients in group B received Silyamrin; During the following 36 weeks, all the patients received ADV 10mg per day.RESULTS Among the 116 patients who were enrolled, 115 completed the 48-week therapy, 58 patients in Group A and 57 in Group B. At week 12, serum HBV DNA levels of Group A was reducted from 6.81 ± 0.776 to 4.31 ± 1.480 , while Group B was from 6.79 ±0.906 to 5.89 ± 1.341. The reduction of serum HBV DNA levels(2.453 ± 1.640. vs. 0.899±1.329, respectively, p<0.001), normalization rate of ALT (46.55 %. vs. 22.80% , p<0.001), undetectable rate of serum HBV DNA (12.07%. vs. 0.00%, p<0.001), negative rate of HBeAg (25. 86% . vs. 5.26%, p<0. 001) and HBeAg seroconversion rate (10. 34% . vs. 3.51%, p<0.05)of Group A were higher than those of Group B. At week 48, serum HBV DNA levels of Group A reducted to 2. 93±2.233, which was lower than Group B(4. 09+1.935), and the reduction rate of HBV level (62. 52%, vs 54.95%), normalization rate of ALT (67.24 % .vs.61.40%), undetectable rate of serum HBV DNA (41.38%.vs.36.84%), undetectable rate of HBeAg (44.82%.vs.40.35%), and HBeAg seroconversion rate (20.69%.vs. 19.30%)of Group A were higher than those of Group B, but there exists no statistic significance. After 48 weeks of treatment, the incidence of clinical adverse events in Group A was similar to that in Group B in week 12(9. vs. 9), week 24(11.vs. 12) and week 48(13.vs. 14).There exists no statistic significance between the two groups.CONCLUSIONS In patients with HBeAg-positive chronic hepatitis B, ADV treatment was safety and valid for reducing serum HBV DNA and increasing HBeAg seroconversion rates.
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