Efficacy of telbivudine on hepatitis B viral status and liver function in patients with hepatitis B virus-related hepatocellular carcinoma

Abstract

Background: Antiviral therapy with nucleos(t)ide analogues has been shown to be effective in improving liver function in patients with chronic hepatitis B (CHB). However, antiviral efficacy and safety of telbivudine therapy, one of the nucleoside analogues for CHB has not been evaluated in hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). Methods: A total of 223 CHB patients consecutively treated with 600 mg/day telbivudine for at least 6 months, 80 had HCC (HCC group; A) whilst 143 did not have HCC (non-HCC group; B). During telbivudine treatment, biochemical, virological and serological parameters were regularly monitored. Results: There was no significant difference in baseline characteristics between two groups. The median duration of telbivudine treatment was 16.1 months. At Month 21, a median change in serum HBV DNA from baseline was similar between the groups (A vs B: -3.5 vs -4.0 log10 IU/ml, P = 0.671). The cumulative complete virologic response (serum HBV DNA < 12 IU/ml) was also comparable (A vs B: 57.5% vs 65.7%, P = 0.318). ALT normalization was 63% in the HCC group and 81% in the non-HCC group. HBeAg seroconversion was 5.7% in the HCC group and 4.4% in the non-HCC group. The cumulative rate of viral breakthrough was higher in the non-HCC group, but it could not reach to significant difference (17.5% vs 29.3%, P = 0.055). There was no hepatitis flare in both group, representing telbivudine was effective to prevent HBV reactivation during anti-HCC treatment. Telbivudine treatment improved liver function showing an increase in serum albumin level (P <0.001) and decrease in Child-Pugh scores (P <0.001). No serious side effects were found in all patients. Conclusion: Telbivudine had comparable antiviral efficacy and safety both in patients with HCC and non-HCC. During telbivudine treatment, there appears to be no hepatitis flare due to HBV reactivation from anti-HCC treatment and liver function of patients has been improved.