Clinical outcome of lamivudine-resistant chronic hepatitis B patients with compensated cirrhosis under adefovir salvage treatment. Importance of HCC surveillance.

Background: Data concerning the outcome of lamivudine-resistant (LAM-R) chronic hepatitis B (CHB) patients with compensated cirrhosis under adefovir (ADV) treatment are limited. The aim of our study was to evaluate the medium term outcome of these, high-risk for fatal events, patients.

Methods: 31 LAM-R patients with compensated cirrhosis who had been treated with ADV monotherapy (n=8) or ADV plus LAM (n=23) for a mean of 27.6 months, were evaluated. Virological response (VR) was defined as HBV-DNA levels <10(4) copies/ml within the first year of treatment.

Results: Twenty-three patients (74.19%) achieved VR. Six patients (19.35%) developed ADV-related mutations (annual incidence 11%). Liver-related death, liver decompensation and hepatocellular carcinoma (HCC) were observed in 12.9%, 16.12% and 16.12% of patients, respectively. HCC (annual incidence 9.1%) was the main cause of liver decompensation (4/5, 80%) and of liver-related deaths (3/4, 75%). HCC development was not related to patients' age (p=0.440), HBeAg status (p=0.245), HBV genotype (p=0.598), baseline ALT levels (p=0.981), baseline viral load (p= 0.464), VR (p=0.504) as well as emergence of ADV resistance (p=0.871).

Conclusions: ADV suppresses viral replication in more than 70% of LAM-R cirrhotic patients during the first year of treatment. Despite that, HCC is frequently observed in these high-risk patients, irrespective of virological response or emergence of ADV resistance.