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  • Title: [Optimal treatment regimen for patients with HBeAg-positive chronic hepatitis B after suboptimal response to 24 weeks of Peg-IFN α-2a].
    Author: Luo XD, Chen XP, Chen XF.
    Journal: Zhonghua Gan Zang Bing Za Zhi; 2017 Dec 20; 25(12):896-901. PubMed ID: 29325289.
    Abstract:
    Objective: To investigate the optimal treatment regimen for patients with HBeAg-positive chronic hepatitis B (CHB) after suboptimal response to 24 weeks of pegylated interferon (Peg-IFN) α-2a. Methods: A total of 188 patients with HBeAg-positive CHB who had suboptimal response to 24 weeks of Peg-IFN α-2a were randomly divided into entecavir group (n = 93) and telbivudine group (n = 95). The two groups received entecavir 0.5 mg/d and telbivudine 0.6 g/d, respectively, for 208 weeks. After 208 weeks of treatment, the following indices were assessed: HBeAg clearance rate and seroconversion rate, hepatitis B virus (HBV) DNA clearance rate (HBV DNA < 500 IU/ml), safety, and drug resistance rate. The data were subjected to intention-to-treat (ITT) analysis and per protocol (PP) analysis. Univariate and multivariate logistic regression analyses were performed for the drugs used and baseline characteristics in patients with or without HBeAg seroconversion, and stratification analysis was performed based on the baseline HBeAg level. Results: Six cases in the entecavir group and four cases in the telbivudine group did not complete the treatment. Sequential entecavir and telbivudine were well tolerated and safe for all patients. There was a significant difference in HBV DNA clearance rate at 52 weeks of treatment between the entecavir group and the telbivudine group (ITT analysis: 93.55% [87/93] vs 77.89% [74/95], χ (2) = 9.363, P = 0.002; PP analysis: 93.10% [81/87] vs 76.92% [70/91], χ (2) = 9.049, P = 0.003). The suppression rates of HBV DNA at 208 weeks of treatment were 95.70% (89/93) vs 92.63% (88/95) (ITT analysis) and 95.40% (83/87) vs 92.31% (84/91) (PP analysis). There was a significant difference in HBeAg seroconversion rate at 208 weeks of treatment between the entecavir group and the telbivudine group (ITT analysis: 38.71% [36/93] vs 62.11% [59/95], χ (2) = 10.290, P = 0.001; PP analysis: 41.38% [36/87] vs 64.84% [59/91], χ (2) = 9.833, P = 0.002). Univariate and multivariate logistic regression analyses suggested that sequential use of telbivudine, male sex, and the baseline level of HBeAg were significantly associated with HBeAg seroconversion at 208 weeks of treatment (P = 0.003, hazard ratio [HR] = 0.386; P = 0.009, HR = 0.303; P = 0.001, HR = 3.502). Conclusion: For patients with HBeAg-positive CHB after suboptimal response to 24 weeks of Peg-IFNα-2a, sequential use of telbivudine is the optimal treatment regimen according to the baseline level of HBeAg (baseline guidance). The incidence of HBeAg seroconversion during 208 weeks of sequential treatment can be significantly increased according to the HBeAg decline curve in early treatment (24 weeks) and 104 weeks (response guidance). 目的： 探讨聚乙二醇干扰素α-2a治疗HBeAg阳性慢性乙型肝炎24周应答不佳患者的优化治疗路线。 方法： 纳入HBeAg阳性慢性乙型肝炎经聚乙二醇干扰素α-2a治疗24周应答不佳患者188例，随机进入恩替卡韦组（93例，脱落6例，恩替卡韦0.5 mg/d）及替比夫定组（95例，脱落4例，替比夫定0.6 g/d），研究时间208周。检测208周的HBeAg阴转率和血清学转换率、HBV DNA阴转率（HBV DNA < 500 IU/ml）、安全性、耐药率。对数据进行意向性分析（ITT）和符合方案分析（PP）。对出现HBeAg血清学转换病例组与未出现HBeAg血清学转换病例组所使用药物及基线特征进行单因素分析、多因素logistic回归分析及根据基线HBeAg水平进行分层分析。 结果： 聚乙二醇干扰素α-2a治疗HBeAg阳性慢性乙型肝炎24周应答不佳患者序贯恩替卡韦及替比夫定均有良好的耐受性及安全性。序贯恩替卡韦组及替比夫定组治疗第52周HBV DNA阴转率为93.55%（87/93）与77.89%（74/95，ITT分析）或93.10%（81/87）与76.92%（70/91，PP分析），差异有统计学意义（ITT分析：χ(2) = 9.363，P = 0.002；PP分析：χ(2) = 9.049，P = 0.003）；治疗208周HBV DNA阴转率为95.70%（89/93）与92.63%（88/95，ITT分析）或95.40%（83/87）与92.31%（84/91，PP分析）。序贯恩替卡韦组及替比夫定组治疗208周HBeAg血清学转换率为38.71%（36/93）与62.11%（59/95，ITT分析）或41.38%（36/87）与64.84%（59/91，PP分析），差异有统计学意义（ITT分析：χ(2) = 10.290，P = 0.001；PP分析：χ(2) = 9.833，P = 0.002）。单因素分析、多因素logistic回归分析均提示替比夫定（P = 0.003，HR = 0.386）、男性（P = 0.009，HR = 0.303）、基线HBeAg水平（P = 0.001，HR = 3.502）与治疗208周出现HBeAg血清学转换相关。 结论： 对聚乙二醇干扰素α-2a治疗HBeAg阳性慢性乙型肝炎24周应答不佳患者，根据基线HBeAg水平，选择替比夫定作为优化治疗方案，可显著提高序贯治疗208周出现HBeAg血清学转换的概率。.
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