[A clinical study of adefovir dipivoxil treatment for chronic hepatitis patients with cirrhosis in their decompensation period].

OBJECTIVE

To evaluate the efficacy and safety of 48 weeks adefovir dipivoxil (ADV) treatment for chronic hepatitis patients with cirrhosis in their decompensation period.

METHODS

Sixty-two chronic hepatitis patients with cirrhosis in their decompensation period were randomly put into two groups. An adefovir dipivoxil (ADV) group: 32 patients treated with 10 mg of ADV a day; and a lamivudine (LMV) group: 30 patients treated with 100 mg of LMV a day. The course of treatment lasted 48 weeks. Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), Alb, TBil, HBeAg, HBV DNA, PCIII, IVC, LN, and HA, renal function, Child-Pugh scores and drug adverse reactions during the treatment of the two groups were checked, compared and analyzed.

RESULTS

The ratios of recovery for liver functions and the negativity rate of HBV DNA, HBeAg, including sero-conversion rate of HBeAg/HBeAb, were increased with prolongation of the treatment period; however, the differences between the two groups were not statistically significant (P > 0.05). Two patients treated with lamivudine suffered from YMDD variation at the 48th week; the ratio of variation was 6.7%. No YMDD variation happened in the ADV group. On the 24th week of the treatment, the levels of the serum markers of hepatic fibrosis declined obviously, compared with those prior to the treatment (P < 0.01). There were no significant statistical differences of those levels between the two groups (P > 0.05). No significant differences of Child-Pugh scores were noticed between the two groups (P > 0.05). No drug related renal function impairment was found during the treatment. Two patients of each group had adverse drug reactions but all were mild.

CONCLUSION

The efficacy and safety of adefovir dipivoxil and lamivudine treatment for the above patients were similar, but the ratio of emerging virus-resistant strains was lower in the adefovir dipivoxil treatment group.