A comparative study on the efficacy between interferon alpha monotherapy and lamivudine-interferon combination therapy in chronic hepatitis B patients

Lim, Tae Hyung; Jeong, Dong Seong; Lee, Sang; Han, Seung Ho; Chung, Suk Hwan; Kum, Dong Sung; Joo, Hee Rin; Jang, Jin Seok; Lee, Jong Hoon; Rho, Myoung Hwan; Han, Sang Young; Choi, Seok Ryeol; Shin, Woo Won

Abstract

BACKGROUND: At present, lamivudine-interferon combination therapy is being tried on chronic hepatitis B patients who had no significant response to interferon-alpha mono-therapy. The therapeutic effect of lamivudine-interferon combination therapy is showing various outcomes depending on the period of therapy and the status of the patient. Thus we conducted this study to compare the therapeutic effect of lamivudine-interferon combination therapy versus interferon-alpha monotherapy in korean patients with chronic hepatitis B. METHOD: Among the chronic hepatitis B patients, 138 patients who showed positive to HBeAg, and serum HBV DNA levels are over 5 pg/mL and serum ALT levels are over 40 IU/L were allocated to IFN-alpha monotherapy group (70 patients) and lamivudine-interferon combination therapy group (66 patients). We compared two groups on ALT normalization rate, HBeAg seroconversion rate, HBV DNA loss rate and HBeAg loss rate in both group. IFN-alpha was percutaneously injected three times a week. Mean administered dose was 27125 (+/-11841) MU and mean administered duration was 6.4 (+/-1.6) months. Lamivudine was concomitantly and continuously administered with IFN-alpha for over 6 months (mean 13.2 +/- 16.5). The lamivudine therapy was terminated at the point when HBeAg turned positive into negative.
RESULTS
Mean follow-up period was 28 months. HBeAg loss rate was 40.9% in lamivudine- interferon combination therapy group and 28.6% in IFN-alpha monotherapy group on the 12th month of the therapy, showing there was no significant difference between the two groups (p=0.13). HBeAg seroconversion rate was 40.9% in lamivudine-interferon combination therapy group and 21.4% in IFN-alpha monotherapy group on the 12th month of the therapy (p=0.014). HBV DNA loss rate was 90.9% in lamivudine-interferon combination therapy group and 88.6% in IFN-alpha monotherapy group within 12months of the therapy, showing there was no significant difference between the two groups (p=0.35). Serum ALT normalization rate was 92.4% in lamivudine-interferon combination therapy group and 85.7% in IFN-alpha monotherapy group within 12months of the therapy, showing there was no significant difference between the two groups (p=0.11).
CONCLUSION
The lamivudine-interferon combination therapy compared to the Interferon-alpha monotherapy showed a statistically significant higher HBeAg seroconversion rate.