Park Chan Ho, Jung Seok Won, Shin Jung Woo, Bae Mi Ae, Lee Yoon Im, Park Yong Tae, Chung Hwa Sik, Park Neung Hwa
Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Korea.
Clin Mol Hepatol. 2016 Mar;22(1):152-9. doi: 10.3350/cmh.2016.22.1.152. Epub 2016 Mar 28.
BACKGROUND/AIMS: Tenofovir disoproxil fumarate (TDF) exhibits similar antiviral efficacy against treatment-naïve and lamivudine (LAM)-resistant chronic hepatitis B (CHB). However, there are few clinical reports on the antiviral effects of TDF-LAM combination therapy compared to TDF monotherapy in patients with LAM-resistant CHB.
We investigated the antiviral efficacy of TDF monotherapy vs. TDF-LAM combination therapy in 103 patients with LAM-resistant CHB.
The study subjects were treated with TDF alone (n=40) or TDF-LAM combination therapy (n=63) for ≥6 months. The patients had previously been treated with TDF-based rescue therapy for a median of 30.0 months (range, 8-36 months). A virologic response (VR) was achieved in 99 patients (96.1%): 95.0% (38/40) of patients in the TDF monotherapy group and 96.8% (61/63) of patients in the TDF-LAM combination therapy group. The VR rates were not significantly different between the TDF monotherapy and TDF-LAM combination therapy groups (88.9 vs. 87.3% at month 12, and 94.4 vs. 93.7% at month 24, log-rank p=0.652). Univariate and multivariate analyses revealed that none of the pretreatment factors were significantly associated with VR.
TDF monotherapy was as effective as TDF-LAM combination therapy for maintaining viral suppression in the vast majority of patients with LAM-resistant CHB, which suggests that TDF add-on therapy with LAM is unnecessary.
背景/目的：替诺福韦酯（TDF）对初治和拉米夫定（LAM）耐药的慢性乙型肝炎（CHB）患者具有相似的抗病毒疗效。然而，与TDF单药治疗相比，TDF-LAM联合治疗对LAM耐药CHB患者抗病毒效果的临床报道较少。
我们调查了103例LAM耐药CHB患者中TDF单药治疗与TDF-LAM联合治疗的抗病毒疗效。
研究对象接受TDF单药治疗（n = 40）或TDF-LAM联合治疗（n = 63）≥6个月。患者此前接受基于TDF的挽救治疗的中位时间为30.0个月（范围8 - 36个月）。99例患者（96.1%）实现了病毒学应答（VR）：TDF单药治疗组95.0%（38/40）的患者和TDF-LAM联合治疗组96.8%（61/63）的患者。TDF单药治疗组与TDF-LAM联合治疗组的VR率无显著差异（第12个月时分别为88.9%和87.3%，第24个月时分别为94.4%和93.7%，对数秩检验p = 0.652）。单因素和多因素分析显示，治疗前因素均与VR无显著相关性。
对于绝大多数LAM耐药CHB患者，TDF单药治疗在维持病毒抑制方面与TDF-LAM联合治疗同样有效，这表明TDF联合LAM的附加治疗是不必要的。
