Shanghai Jing An Qu Central Hospital, No. 259 Xikang Road, Shanghai, 200040, China,
Hepatol Int. 2008 Dec;2(4):486-93. doi: 10.1007/s12072-008-9088-8. Epub 2008 Aug 30.
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine at 48 weeks in nucleoside-naïve Chinese patients with chronic hepatitis B (CHB). We evaluated the effect of continued entecavir and lamivudine treatment in patients who continued treatment in year 2 and the off-treatment durability of patients who achieved a protocol-defined consolidated response at week 48.
Chinese adults (n = 519) with CHB were randomized to a minimum of 52 weeks of treatment with entecavir 0.5 mg/day or lamivudine 100 mg/day. Patients with a consolidated response at week 48 (HBV DNA <0.7 MEq/ml for >/=24 weeks, ALT <1.25 times ULN, and, if HBeAg(+) at baseline, loss of HBeAg for at least 24 weeks) stopped treatment at week 52 and were followed off-treatment. Patients with a partial response at week 48 (HBV DNA <0.7 MEq/ml in the absence of other criteria for a consolidated response) could continue blinded treatment for up to 96 weeks. Patients were assessed for HBV DNA, ALT normalization, safety, and, if HBeAg(+) at baseline, for HBe seroconversion. Cumulative proportions of all treated patients who ever achieved these responses were also analyzed.
Among patients treated during year 2 (entecavir: n = 193; lamivudine: n = 145), 74% of entecavir-treated and 41% of lamivudine-treated patients had HBV DNA <300 copies/ml by PCR at end of dosing and 96% of entecavir-treated and 82% of lamivudine-treated patients normalized ALT. Eleven percent of entecavir-treated versus 19% of lamivudine-treated patients underwent HBe seroconversion during year 2. Cumulative confirmed analysis for all treated patients through 96 weeks showed that 79% of entecavir-treated versus 46% of lamivudine-treated patients (p < 0.0001) achieved HBV DNA <300 copies/ml by PCR. Similar proportions of entecavir- and lamivudine-treated patients achieved confirmed ALT normalization and HBe seroconversion. Safety profile was comparable for both treatment groups.
Through 96 weeks of treatment, entecavir resulted in continued clinical benefit in nucleoside-naïve Chinese patients with CHB, with a safety profile comparable with lamivudine.
在核苷初治的中国慢性乙型肝炎（CHB）患者中，恩替卡韦在 48 周时表现出优于拉米夫定的病毒学和生化优势。我们评估了继续使用恩替卡韦和拉米夫定治疗的患者在第 2 年继续治疗的效果，以及在第 48 周达到方案定义的综合应答的患者停药后的持久性。
519 例 CHB 中国成年人被随机分配至恩替卡韦 0.5mg/天或拉米夫定 100mg/天的至少 52 周治疗。在第 48 周达到综合应答的患者（HBV DNA<0.7 MEq/ml 且持续>24 周，ALT<1.25 倍 ULN，并且如果基线时 HBeAg(+)，则 HBeAg 丢失至少 24 周）在第 52 周停止治疗，并进行停药后随访。在第 48 周达到部分应答的患者（HBV DNA<0.7 MEq/ml 但缺乏综合应答的其他标准）可以继续接受双盲治疗最多 96 周。评估所有治疗患者的 HBV DNA、ALT 正常化、安全性，以及如果基线时 HBeAg(+)，则评估 HBe 血清学转换。还分析了所有治疗患者中达到这些应答的累积比例。
在第 2 年治疗的患者中（恩替卡韦：n=193；拉米夫定：n=145），恩替卡韦治疗组的 74%和拉米夫定治疗组的 41%患者在停药时 HBV DNA 通过 PCR<300 拷贝/ml，恩替卡韦治疗组的 96%和拉米夫定治疗组的 82%患者 ALT 正常化。在第 2 年期间，恩替卡韦治疗组的 11%患者和拉米夫定治疗组的 19%患者发生 HBe 血清学转换。通过 96 周治疗，所有治疗患者的累积确认分析显示，恩替卡韦治疗组的 79%患者和拉米夫定治疗组的 46%患者（p<0.0001）HBV DNA 通过 PCR<300 拷贝/ml。恩替卡韦治疗组和拉米夫定治疗组达到确认的 ALT 正常化和 HBe 血清学转换的比例相似。两组的安全性状况相当。
通过 96 周的治疗，恩替卡韦在核苷初治的中国 CHB 患者中持续提供临床获益，安全性与拉米夫定相当。
Zotero 插件