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 背景和目的：在一项治疗HbeAg阴性慢性乙肝的研究中，聚乙二醇干扰素α-2a±拉米夫定治疗结束后24周生化学和病毒学应答率均显著高于拉米夫定单药治疗。对治疗前因素对治疗结束后应答的影响进行了分析。
患者和方法：对518例聚乙二醇干扰素α-2a±拉米夫定或拉米夫定单药治疗患者的数据进行了多变量分析。治疗结束后应答定义为ALT复常和HBV-DNA<20,000拷贝/毫升。结果：在对所有治疗组进行的逻辑回归分析后，聚乙二醇干扰素α-2a（±拉米夫定）治疗、较轻年龄、女性、高基线ALT、低基线HBV-DNA和HBV基因型被确认为是治疗结束后24周联合应答的显著预测因子。在聚乙二醇干扰素α-2a和拉米夫定单药治疗组中，感染基因B和C型的患者较基因D型患者的应答率高（p<0.001），后者对联合治疗的应答率高于聚乙二醇干扰素α-2a单药治疗（p=0.015）。在治疗结束后1年，聚乙二醇干扰素α-2a组应答率经意愿治疗（ITT）分析为19.2%，联合治疗组为19.0%，拉米夫定治疗组为10.0%，基因B或C型患者与聚乙二醇干扰素α-2a±拉米夫定治疗的持续联合应答有关。
结论：接受聚乙二醇干扰素α-2a和/或拉米夫定治疗的患者，基线ALT和HBV-DNA水平、患者年龄、性别和感染基因型显著影响治疗结束24周后的联合应答。治疗结束后1年，HBV基因型是聚乙二醇干扰素α-2a±拉米夫定治疗疗效的显著预测因子。
Gut. 2006 Nov 24; [Epub ahead of print]
Predicting response to peginterferon alfa-2a, lamivudine and the two combined for HBeAg-negative chronic hepatitis B.
Bonino F, Marcellin P, Lau GK, Hadziyannis S, Jin R, Piratvisuth T, Germanidis G, Yurdaydin C, Diago M, Gurel S, Lai MY, Brunetto M, Farci P, Popescu M, McCloud P.
Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Italy.
BACKGROUND AND AIMS: In a trial of patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B, 24-week post-treatment biochemical and virologic response rates with peginterferon alfa-2a +/- lamivudine were significantly higher than with lamivudine alone. The effect of pre-treatment factors on post-treatment responses has been investigated. PATIENTS AND METHODS: Multivariate analyses were performed using available data from 518 patients treated with peginterferon alfa-2a monotherapy +/- lamivudine, or lamivudine monotherapy. A post-treatment response was defined as alanine aminotransferase (ALT) normalisation and hepatitis B virus (HBV) DNA <20,000 copies/mL. RESULTS: In logistic regression analyses across all treatment arms, peginterferon alfa-2a (+/- lamivudine) therapy, younger age, female gender, high baseline ALT, low baseline HBV DNA and HBV genotype were identified as significant predictors of combined response 24 weeks post-treatment. In the peginterferon alfa-2a and lamivudine monotherapy arms, patients infected with genotypes B or C had a higher chance of response than genotype D infected patients (p<0.001), the latter responding better to combination than peginterferon alfa-2a monotherapy (p=0.015). At 1 year post-treatment, response rates by intention-to-treat analysis were 19.2% for peginterferon alfa-2a, 19.0% for combination, and 10.0% for lamivudine-treatment groups, with genotypes B or C associated with a sustained combined response to peginterferon alfa-2a +/-lamivudine therapy. CONCLUSIONS: Baseline ALT and HBV DNA levels, patient age, gender, and infecting HBV genotype significantly influenced combined response 24 weeks post-treatment, in patients treated with peginterferon alfa-2a and/or lamivudine. At 1 year post-treatment HBV genotype was significantly predictive of efficacy for patients treated with peginterferon alfa-2a +/-lamivudine.
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