Short-Term Lamivudine Therapy in Hbeag-Negative Chronic Active Hepatitis B in Taiwan

Abstract

Lamivudine treatment in hepatitis B e antigen (HBeAg)-negative and hepatitis B virus (HBV) DNA-positive chronic hepatitis B (CHB) patients is associated with poor sustained response. A previous study has shown that short-term lamivudine therapy in HBeAg-positive patients with alanine aminotransferase (ALT) >5x upper limit of normal (ULN) could achieve a high HBeAg response rate and low lamivudine resistance rate. We, therefore, prospectively treated 85 HBeAg-negative CHB patients with ALT >5x ULN by lamivudine for 6–12 months. The mean pretreatment levels were as follows: ALT (normal <36 U/l) 533 U/l (range: 180–2,418 U/l); total bilirubin (normal<1.3 mg/dl) 2.0mg/dl (range: 0.2–29.6 mg/dl), HBV DNA (normal, undetectable) 1.6x10⁸ copies/ml (range: 1.4x10⁵-1.7x10⁹ copies/ml). After a mean of 7.4 months (6–12 months) treatment, 69 (81%) patients achieved complete response. In a follow-up, 12 months after stopping lamivudine therapy, 33 (39%) patients showed sustained complete response. Patients with sustained response were younger than the relapsed patients (39.7 ±11.9 years versus 47.0 ±10.3 years; P=0.005). The emergence of lamivudine-resistant variant HBV was documented in two patients (2%). It is concluded that in HBeAg-negative chronic hepatitis B patients with ALT levels above 5x ULN, a 6–12 month course of lamivudine therapy may achieve sustained an off-treatment response in approximately one-third of patients.