Objective: To study the efficacy and durability of generic adefovir dipivoxil (ADV) in patients with HBeAg positive chronic hepatitis.
Methods: 54 nucleosides-naïve patients with HBeAg positive chronic hepatitis were enrolled in this randomized, double-blinded, placebo-controlled, prospective study. 38 patients received ADV (10 mg once daily) and the others received placebo. Then all the patients were treated with ADV for 96 weeks and were followed up for 12 weeks.
Results: (1) At week 12, the level of ALT declined significantly in ADV group(135.84 +/- 10.63 U/L to 58.92 +/- 4.95 U/L, P < 0.001) compared with placebo group (145.56 +/- 17.19 U/L to 159.50 +/- 37.05 U/L) (P < 0.001). The HBV-DNA level also declined significantly in adefovir group compared with placebo group (2.51 vs. 1.04 log10 copies/ml, P < 0.001). (2) The rates of normal ALT, normal of AST and undetectable HBV-DNA at 48 and 96 weeks of therapy with ADV were 63.30%, 70.50%, 87.80%, 88.60%, 53.06%, 54.55%, respectively. (3) There were 17 patients discontinuated ADV after 96 weeks. The follow-up results showed that HBV-DNA became positive again in all these 17 patients and abnormal liver function developed in 88.24% (15/17) patients.
Conclusions: Treatment of chronic hepatitis B with generic ADV was effective and well tolerated, but relapse may develop when treatment was discontinued.