Disorders of Liver : Entecavir Provides Inferior Viral Load Reduction In Lamivudine Resistant Patients To In Naive patients-Preliminary Report = Disorders of Liver : Entecavir Provides Inferior Viral Load Reduction In Lamivudine Resistant Patients To In Naive patients-Preliminary Report

다국어 초록 (Multilingual Abstract)

Background/Aims: A lot of trials involving nucleoside- naive, lamivudine-resistant patients are needed to determine entecavir`s optimal treatment duration, long-term safety, and durability of response, including rate of resistance. The aim of our study is to compare the efficacy of entecavir (ETV) between chronic hepatitis B (CHB) patients who had not received a mucleoside analogue and who had failed in lamivudine (LMV) therapy. Methods: From July 2006 to April 2007, 77 patients with CHB were treated with ETV from 2 medical institutions in Korea. 77 patients were divided into two groups. 49 patients who had not received a nucleoside analogue were treated with ETV 0.5 mg/d. 28 patients who were resistant to LMV therapy (persistent viremia and documented YMDD mutations while receiving LMV) were switched to ETV 1.0 mg/d. The duration of treatment was 3-9 (median, 7) months. All patients were assessed for HBV DNA, alanine aminotransferase (ALT) normalization, HBeAg sero-conversion, and safety. Results: The rates of virologic response and normalization of ALT levels were significantly higher naive patients than in LMV resistant patients at week 12 and 24, respectively (p=0.015, p=0.003). Mean change from baseline in serum HBV DNA was -4.1, and -5.5 log10 copies/mL for naive patients and -2.5, and -2.6 log10 copies/mL for LMV resistant patients at 12 and 24 weeks, respectively (p＜0.001, p＜0.001). Although there was no virologic breakthrough, only one LMV resistant patient did not show the decline in baseline serum HBV DNA. There were no serious adverse events on-treatment. Conclusions: In patients with LMV resistant CHB, entecavir provides inferior viral loud reduction and ALT normalization compared with naive patients.