Efficacy of combined therapy in patients with hepatitis B virus-related decompensated cirrhosis.
AIM
To investigate the efficacy and safety of combined de novo lamivudine (LAM) and adefovir dipivoxil (ADV) therapy in hepatitis B virus (HBV)-related decompensated liver cirrhosis patients.


METHODS
One hundred and forty patients with HBV-related decompensated cirrhosis were recruited, 70 patients were treated with combined LAM and ADV de novo therapy, and the other 70 patients were treated with LAM alone as controls. The follow-up period was 144 wk. All patients with LAM resistance were shifted to ADV.


RESULTS
The percentage of HBV-related decompensated cirrhosis patients with undetectable HBV DNA in de novo combination group was 51.6% (33/64), 84.2% (48/57), and 92.3% (49/53) by weeks 48, 96, and 144, respectively. In monotherapy group, HBV DNA negativity rate was 46.1% (30/65), 56.1% (32/57), and 39.2% (20/51) by weeks 48, 96 and 144, respectively. There was a significant difference between the two groups by weeks 96 and 144 (P = 0.012 and 0.001). The hepatitis B e antigen seroconversion rate was 28.1% (9/32), 40.0% (12/30), and 53.6% (15/28) in the combination group by weeks 48, 96 and 144, respectively, and 24.2% (8/33), 31.0% (9/29), and 37.0% (10/27) by weeks 48, 96 and 144, respectively, in monotherapy group. A total of 68.6% (44/64), 84.2% (48/57), and 92.5% (49/53) patients achieved alanine aminotransferase (ALT) normalization by weeks 48, 96 and 144, respectively in the combination group. In monotherpy group, the ALT normalization rate was 64.6% (42/65) by week 48, 73.7% (42/57) by week 96, and 80.4% (41/51) by week 144. No patients in the combination group exhibited detectable resistance for at least 144 wk. The cumulative resistance rate in monotherapy group at weeks 48, 96, and 144 was 20.0%, 36.8%, and 56.9%. Both combination group and monotherapy group demonstrated an improvement in Child-Turcotte Pugh and Model for End-Stage Liver Disease scores at weeks 48, 96, and 144. All patients tolerated both combination and monotherapy. The ceratinine levels and glomerular filtration rate remained normal in all patients during the follow-up period.


CONCLUSION
In HBV-related decompensated liver cirrhosis patients, the combined de novo LAM and ADV therapy is more efficacious and safer compared to LAM alone.
['Lv|Guo-Cai|GC|', 'Yao|Jin-Mei|JM|', 'Yang|Yi-Da|YD|', 'Zheng|Lin|L|', 'Sheng|Ji-Fang|JF|', 'Chen|Yu|Y|', 'Li|Lan-Juan|LJ|']
D000225:Adenine D000328:Adult D000410:Alanine Transaminase D000998:Antiviral Agents D015415:Biomarkers D016009:Chi-Square Distribution D002681:China D004279:DNA, Viral D024882:Drug Resistance, Viral D004359:Drug Therapy, Combination D005260:Female D006509:Hepatitis B D006515:Hepatitis B virus D006801:Humans D053208:Kaplan-Meier Estimate D019259:Lamivudine D008103:Liver Cirrhosis D008297:Male D008875:Middle Aged D063065:Organophosphonates D013997:Time Factors D016896:Treatment Outcome D019562:Viral Load
Efficacy Lamivudine Adefovir dipivoxil Liver cirrhosis Alanine transaminase