AASLD2014:基线预测工具的选择HBeAg阴性慢性乙肝患者谁拥有实

StephenW

1885A baseline predictive tool for selecting HBeAg-negative chronic hepatitis B patients who have a high probability of achieving sustained immune control with peginterferon alfa-2a
Pietro Lampertico1, Vivien Rothe2, Antonietta Caputo3, George V. Papatheodoridis4;1AM & A Migliavacca Center for Liver Disease, 1st Gastroenterology Unit, Fondazione IRCCS Ca' Granda Osped-ale Maggiore Policlinico, Universita degli Studi di Milano, Milan, Italy; 2IST GmbH, Mannheim, Germany; 3Roche S.p.A., Monza, Italy; 4Department of Gastroenterology, Athens University Medical School, Laiko General Hospital, Athens, Greece
Objective: Peginterferon (PegIFN) alfa-2a induces serologic responses that are durable after the withdrawal of treatment in patients with HBeAg-negative chronic hepatitis B (CHB). Not all patients achieve a response; thus, the ability to identify patients likely to respond would be clinically useful. We aimed to develop a simple scoring system that can prospectively estimate a patient's chance of achieving sustained immune control (SIC) and sustained response (SR) with PegIFN alfa-2a.
Methods: This retrospective analysis used data from HBeAg-negative CHB patients who received PegIFN alfa-2a 180 mg/week ± lamivudine for 48 weeks in 2 large studies. SIC was defined as HBV DNA <2000 IU/mL and SR was defined as HBV DNA <2000 IU/mL plus normal ALT after 48 weeks of untreated follow-up. Logistic regression analyses identified predictors of response, and generalized additive models with logit link identified cut-points for continuous predictors. The baseline scoring system comprised 5 factors; points were assigned as follows: genotype C (+1), HBV DNA <250,000 IU/mL (+1), ALT ≥5 × upper limit of normal (+1), HBsAg: ≥1000 but <3500 IU/ mL (+1), <1000 IU/mL (+2); age: 30–45 years (+1), <30 years (+2). The overall baseline score ranged from 0–7; higher scores indicated a higher chance of SIC and SR.
Results: Among patients with data available at Week 48 post-treatment (N=263), 32%, 49%, and 19% of patients had scores of 0-1, 2-3, or ≥4 points, respectively. SR and SIC rates improved as baseline scores increased (Table). At Week 48 post-treatment, SIC and SR rates were 61% and 45%, respectively, in patients with scores ≥4 and 11% (negative predictive value [NPV] 89%) and 8% (NPV 92%) in patients with scores 0-1. The increases in SIC and SR rates with increasing baseline scores were consistent across both studies and independent of lamivudine therapy.
Conclusion: The proposed baseline scoring system uses readily available baseline characteristics to identify HBeAg-negative CHB patients who have a low or high chance of achieving SR or SIC with PegIFN alfa-2a. The benefit/risk ratio should be carefully considered before initiating treatment in patients with scores of 0–1, while prediction of response might be further improved by application of established on-treatment prediction rules (e.g., PARC) in patients with scores ≥2. Funded by Roche

Disclosures:
Pietro Lampertico - Advisory Committees or Review Panels: BMS, Roche, Gilead; Speaking and Teaching: BMS, Roche, Gilead, GSK, MSD
Antonietta Caputo - Employment: Roche
George V. Papatheodoridis - Advisory Committees or Review Panels: Merck, Novartis, Abbvie, Boerhinger, Bristol-Meyer Squibb, Gilead, Roche, Janssen, GlaxoSmith Kleine; Grant/Research Support: Roche, Gilead, Bristol-Meyer Squibb, Abbvie, Janssen; Speaking and Teaching: Merck, Bristol-Meyer Squibb, Gilead, Roche, Janssen, Abbvie
The following people have nothing to disclose: Vivien Rothe

StephenW

1885
基线预测工具的选择HBeAg阴性慢性乙肝患者谁拥有实现持久免疫控制与聚乙二醇干扰素α-2a的概率高
彼得Lampertico1，费雯丽Rothe2，Antonietta酒店Caputo3，乔治五世Papatheodoridis4;
上午01点＆A Migliavacca中心肝病，消化内科1单位，基金会IRCCS钙'格兰达Osped-ALE教堂就是Policlinico，UNIVERSITA阿布鲁Studi大学米兰，米兰，意大利; 2IST有限公司，德国曼海姆; 3Roche S.p.A的蒙扎，意大利;消化内科，雅典大学医学院，Laiko总医院，雅典，希腊4Department

目的：聚乙二醇干扰素（PegIFN）α-2A诱导血清学反应，是治疗的患者停药HBeAg阴性慢性乙型肝炎（CHB）后，坚固耐用。并不是所有的患者达到的响应;因此，为了确定患者有可能作出反应的能力将是临床上有用。我们的目的是开发一个简单的评分系统，可以前瞻性地评估实现持续的免疫控制（SIC）和PegIFNα-2A持续应答（SR）的病人的机会。方法：回顾性分析谁在2个大型研究收到的PegIFNα-2A180毫克/周±拉米夫定治疗48周，HBeAg阴性慢性乙肝患者使用的数据。 SIC定义为HBV DNA<2000 IU/ mL和SR定义为HBV DNA<2000 IU/ mL的加ALT正常48周未治疗后随访。 Logistic回归分析确定的响应的预测，并与罗吉特链接确定切点为连续预测广义加法模式。基准评分系统由5个因素;点被分配如下：C型（1），HBV DNA<25万国际单位/毫升（1），谷丙转氨酶≥5×正常值上限（1），乙肝表面抗原：≥1000但<3500 IU/毫升（+ 1），<1000 IU/毫升（2）;年龄：30-45岁（1），<30岁（2）。整体基准分数介于0-7;分数越高表示SIC和SR的机会较高。结果：患者提供的数据，在48周后，治疗组（n=263），32％，49％和19％的患者有0-1比分2-3，或≥4点，分别为。 SR和SIC率提高为基准分数增加（见表）。在48周治疗后，SIC和SR率分别为61％和45％，在患者的分数≥4和11％（阴性预测值[NPV]89％）和8％（NPV92％）患者的比分0-1。在SIC的增加和SR率随基准得分均在这两个研究是一致的，独立的拉米夫定治疗。结论：该基线评分系统采用现成的基线特征识别HBeAg阴性慢性乙肝患者谁拥有实现SR或SIC与PegIFNα-2a的低或高的机会。的利益/风险比应慎重考虑在患者的0-1分数开始治疗之前，同时响应的预测可能是由应用程序的既定的处理的预测规则（例如，PARC）的患者得分≥2得到进一步改善。由罗氏公司资助
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披露：

彼得Lampertico - 咨询委员会或审查小组：拜耳，罗氏，吉利德;口语和教学：BMS，罗氏，基列，葛兰素史克，MSD

Antonietta酒店卡普托 - 就业：罗氏

乔治五世Papatheodoridis - 咨询委员会或审查小组：默克，诺华，Abbvie，Boerhinger，百迈耶施贵宝，Gilead公司，罗氏，杨森，GlaxoSmith克莱;格兰特/研究支持：罗氏公司，Gilead公司，百迈耶施贵宝，Abbvie，扬森;口语和教学：默克，百迈耶施贵宝，Gilead公司，罗氏，杨森，Abbvie

下面的人都没有透露：费雯·罗斯

龙

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