Jeong In du, Park Neung Hwa, Kim Byung Chul, Park Jee Hyun, Seo Kwang Won, Kim Dae-Hyun, Joo Kwang Ro, Kim Do Ha
Department of Internal Medicine, Ulsan University College of Medicine, Ulsan, Korea.
Taehan Kan Hakhoe Chi. 2003 Jun;9(2):69-78.
BACKGROUND/AIMS: Lamivudine therapy is effective in inhibiting HBV replications in patients with HBeAg-negative chronic liver disease. However, the sustained response rate appears to be particularly poor, because the vast majority of patients relapse soon after cessation of therapy. The aim of this study was to evaluate the efficacy of lamivudine, the breakthrough rate, and the relapse rate of discontinuing therapy after response in patients with HBeAg-negative chronic liver disease.
Fifty-nine patients with HBeAg-negative chronic liver disease who have received lamivudine for at least 6 months, were studied. The mean duration of treatment was 14 months. Complete response was defined as undetectable serum HBV DNA by bDNA and normalization of ALT levels. Once HBV DNA disappearance and ALT normalization were observed, lamivudine therapy was continued for at least two additional months. The mean follow-up after cessation of treatment was 6 (1-22) months.
Fifty-six patients were undetectable HBV DNA. The cumulative HBV DNA loss rates at 3 months and 5 months were 90% and 95%, respectively. The ALT normalization was observed in 52 patients. The cumulative ALT normalization rates at 6 months and 10 months were 78% and 86%, respectively. The complete response was observed in 52 patients. The cumulative rates of complete response at 10 months and 18 months were 80% and 88%, respectively. A predictive factor for complete response was only the duration of lamivudine treatment. Virological breakthrough was observed in 5 (8.5%). Thirty-four patients stopped taking lamivudine after 7.7 (2-15) months of the additional therapy. Seventeen of those patients (50%) experienced relapse. The cumulative relapse rates at 3 months, 6 months and 10 months were 24%, 47%, and 66%, respectively. The only predictive factor for relapse was the duration of additional lamivudine treatment after response.
Lamivudine was an effective treatment of HBeAg negative chronic liver disease. Relapse, however, was usually observed after cessation of lamivudine. Our results showed that long-term lamivudine therapy is required in order to decrease the high relapse rates in patients with HBeAg-negative chronic liver disease.
背景/目的：拉米夫定治疗对HBeAg阴性慢性肝病患者的HBV复制具有抑制作用。然而，其持续应答率似乎特别低，因为绝大多数患者在治疗停止后很快复发。本研究旨在评估拉米夫定对HBeAg阴性慢性肝病患者的疗效、突破率以及治疗应答后停药的复发率。
对59例接受拉米夫定治疗至少6个月的HBeAg阴性慢性肝病患者进行研究。平均治疗时长为14个月。完全应答定义为通过分支DNA检测血清HBV DNA不可测且ALT水平正常化。一旦观察到HBV DNA消失且ALT正常化，拉米夫定治疗至少再持续两个月。治疗停止后的平均随访时间为6（1 - 22）个月。
56例患者的HBV DNA不可测。3个月和5个月时的累积HBV DNA丢失率分别为90%和95%。52例患者ALT正常化。6个月和10个月时的累积ALT正常化率分别为78%和86%。52例患者出现完全应答。10个月和18个月时的累积完全应答率分别为80%和88%。完全应答的唯一预测因素仅是拉米夫定治疗时长。5例（8.5%）出现病毒学突破。34例患者在额外治疗7.7（2 - 15）个月后停止服用拉米夫定。其中17例患者（50%）复发。3个月、6个月和10个月时的累积复发率分别为24%、47%和66%。复发的唯一预测因素是应答后额外拉米夫定治疗的时长。
拉米夫定是治疗HBeAg阴性慢性肝病的有效药物。然而，拉米夫定停药后通常会出现复发。我们的结果表明，为降低HBeAg阴性慢性肝病患者的高复发率，需要长期使用拉米夫定治疗。
