Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.
Division of Infectious Diseases, State Key Laboratory of Biotherapy, Sichuan University, Chengdu, Sichuan, China.
J Viral Hepat. 2020 Jul;27(7):731-738. doi: 10.1111/jvh.13275. Epub 2020 Feb 27.
Not all treatment-naïve patients receiving entecavir (ETV) or tenofovir disoproxil fumarate (TDF) therapy can achieve complete virological response, and many factors may be related with the outcome of partial virological response. This study aimed to determine whether the manner of drug administration affects the antiviral efficacy of ETV/TDF monotherapy. All eligible patients were divided into complete or partial response cohorts based on their virological response following 24-week therapy. Factors related with partial response were evaluated. Patients with partial response were further grouped depending on whether they later adjusted the manner of drug administration, and the antiviral efficacy was compared between the two groups during prolonged treatment. A total of 518 patients were enrolled. Suboptimal drug administration (OR 77.511, P = .000), positive-HBeAg (OR 3.191, P = .000) and ETV treatment (OR 2.537, P = .001) were identified as independent risk factors for partial response. Among patients with partial response, 213 were in the adjusted group and 76 were in the unadjusted group. The percentages of patients with undetectable serum HBV DNA (78.9% vs 31.6%, P < .001) and with normal alanine aminotransferase (ALT) (88.7% vs 68.4%, P < .001) were both higher in the adjusted group than that in unadjusted group following a further 6-month therapy. In conclusion, the manner of drug administration is an important factor influencing the efficacy of ETV/TDF therapy, and optimal drug administration manner can help to increase antiviral efficacy and rescue patients with partial response.
并非所有接受恩替卡韦（ETV）或替诺福韦酯（TDF）治疗的初治患者都能达到完全病毒学应答，许多因素可能与部分病毒学应答的结果有关。本研究旨在确定药物给药方式是否影响 ETV/TDF 单药治疗的抗病毒疗效。所有符合条件的患者均根据 24 周治疗后的病毒学应答分为完全或部分应答队列。评估与部分应答相关的因素。根据是否调整药物给药方式将部分应答患者进一步分组，并比较两组在延长治疗期间的抗病毒疗效。共纳入 518 例患者。药物给药方式不佳（OR 77.511，P =.000）、HBeAg 阳性（OR 3.191，P =.000）和 ETV 治疗（OR 2.537，P =.001）是部分应答的独立危险因素。在部分应答患者中，213 例调整了药物给药方式，76 例未调整。调整组患者血清 HBV DNA 不可检测（78.9% vs 31.6%，P <.001）和丙氨酸氨基转移酶（ALT）正常（88.7% vs 68.4%，P <.001）的比例均高于未调整组进一步 6 个月治疗后。总之，药物给药方式是影响 ETV/TDF 治疗疗效的重要因素，优化药物给药方式有助于提高抗病毒疗效并挽救部分应答患者。
