Entecavir Is Superior to Lamivudine in Reducing Hepatitis B Virus DNA in Patients With Chronic Hepatitis B Infection

Abstract Background & Aims: Entecavir is a novel and selective nucleoside analogue with potent activity against hepatitis B virus (HBV). Methods: In a 24-week, double-blind, randomized, multicenter, phase II clinical trial, the safety and efficacy of entecavir (0.01 mg/day, 0.1 mg/day, or 0.5 mg/day orally) were compared with lamivudine (100 mg/day orally). Patients (n = 169) chronically infected with HBV (hepatitis B e antigen [HBeAg]-positive and -negative) were evaluated for efficacy. Results: Compared with lamivudine, entecavir reduced HBV DNA by an additional 0.97 log 10 at the 0.1-mg/day dose and an additional 1.28 log 10 at the 0.5-mg/day dose ( P P = 0.008). In both treatment arms, very few patients achieved HBeAg loss and/or seroconversion by week 22. More patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase (ALT) levels at week 22 compared with lamivudine ( P = not significant). Entecavir was well tolerated; most adverse events were mild to moderate, transient, and comparable in all study arms. Conclusions: This study showed that entecavir has potent antiviral activity against HBV at 0.1-mg/day and 0.5-mg/day doses, both of which were superior to lamivudine in chronically infected HBV patients. GASTROENTEROLOGY 2002;123:1831-1838