J Korean Med Sci.  2010 Jun;25(6):882-887. 10.3346/jkms.2010.25.6.882.

Clinical Efficacy of a 24-months Course of Lamivudine Therapy in Patients with HBeAg Negative Chronic Hepatitis B: A Long-term Prospective Study

• Paik YH
• Kim JK
• Kim DY
• Park JY
• Ahn SH
• Han KH
• Chon CY
• Lee KS

• KMID: 2150867
• DOI: http://doi.org/10.3346/jkms.2010.25.6.882

Abstract

The optimal duration of oral nucleos(t)ide analogue therapy for HBeAg negative chronic hepatitis B (CHB) has not been defined. The aim of this study was to investigate the clinical efficacy of 24-months course of lamivudine therapy in patients with HBeAg negative CHB in Korea. A total of 50 Korean patients with HBeAg negative CHB were prospectively enrolled. The patients received 100 mg/day of lamivudine orally for 24 months. Patients who showed complete response at 24 months to lamivudine therapy stopped treatment, and regular follow-up was done thereafter. The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months. The complete response rate at months 12 and 24 were 86.0% (43/50) and 86.0% (43/50), respectively, and the clinical breakthrough at months 12 and 24 were 4.0% (2/50) and 14.0% (7/50), respectively. The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively. In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

Keyword

Hepatitis B, Chronic; Treatment Outcome; Lamivudine; Antiviral Agents; Hepatitis B e Antigens

Figure

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  Fig. 1 Complete response rate (hatched bar) and breakthrough rate (black bar) during a 24 months-course of lamivudine therapy in HBeAg negative CHB patients. Complete response was defined as having both ALT normalization and HBV DNA undetectability (<0.5 pg/mL) as measured by the hybrid capture assay. Clinical breakthrough was defined as HBV DNA positive conversion with ALT re-elevation.

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  Fig. 2 Expected durability of response after cessation of lamivudine in 43 patients who showed complete response at 24 months of lamivudine therapy (Kaplan-Meier analysis). Durability of response rates at 1, 2, and 3 yr are 79.1%, 64.0%, and 56.9%, respectively.

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  Fig. 3 Complete response during re-treatment in patients who relapsed after stopping lamivudine therapy. Complete response rate at 12 and 24 months of re-treatment was 100% and 70.0%, respectively.

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  Fig. 4 A flow chart of a 24-months course of lamivudine therapy in HBeAg negative CHB patients. ETR, end of treatment response.

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