APASL2013经验慢性B型肝炎患者恩替卡韦的抗病毒效果

StephenW

The Antiviral Effects of Entecavir in Nucleos(t)ide Analogue-experienced Chronic Hepatitis B Patients   

Guang Dong Tong, Da Qiao Zhou, Hai Hong Tang, Chun Shan Wei, Jin Song He, Ying Jun Zheng, Mei Qiu, Liang Chen, Xiao Zhou Zhou, Wen Jun Xu
Hepatology, Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China

Background/aim: The antiviral effects of ETV-monotherapy were monitored clinically in NA-experienced patients during a median follow-up of 48 months.
Methods: We investigated 212 CHB patients treated with ETV-monotherapy in a cohort study. Among the 104 NA-experienced patients, 84 (including 44 LAM-resistant) were LAM-experienced, and 58 (including 38 ADV-resistant) were ADV-experienced. Rescue therapy (TDF or ADV add-on with ETV) were used for patients with suboptimal response (defined as HBV-DNA >500 copies/ml at a follow-up of 2 years) to ETV or viral breakthrough.
Results: 96% NA-naïve patients exhibited VR(HBV-DNA< 500 copies/ml), whereas only 68% NA-experienced patients exhibited VR, while 13% NA-experienced patients showed suboptimal response to ETV-monotherapy and 18% NA-experienced patients with ETV-monotherapy developed viral breakthrough during a median follow-up of 48 (6-69) months. LAM-experienced patients with LAM-R treated with ETV-monotherapy exhibited significantly decreased VR compared with LAM-naïve patients (HR=0.163; P=0.0013). However, the antiviral efficacy of ETV was not decreased for LAM-experienced patients without LAM-R (HR=0.63; P=0.584). In ADV-experienced patients, the antiviral effect of ETV-monotherapy was unaffected compared with ADV-naïve patients regardless whether ADV-R was developed (HR=0.58; P=0.253) or not (HR 0.28; P=0.52). 14 patients with suboptimal response received rescue therapy (6 with TDF and 8 with ADV add-on), and 13 (93%) patients exhibited VR during a median follow-up of 20 (15-32) months. 19 patients with viral breakthrough also received rescue therapy (9 with TDF and 10 with ADV add-on), and 16 (84%) patients exhibited VR during a median follow-up of 19 (16-28) months.
Conclusion: The antiviral efficacy of ETV was not affected by either the prior ADV treatment or LAM treatment without LAM-R for a follow-up of 48 months. Patients with LAM-R exhibited lower VR rate than LAM-naïve patients. For patients who failed to show VR by ETV- monotherapy, co-administration of ADV or TDF still could achieve VR.


Assigned speakers:
Prof. Guang Dong Tong, Shenzhen Hospital of Traditional Chinese Medicine , Shenzhen , China

Assigned in sessions:
07.06.2013, 08:30-17:30, PT-4, HEP B Clinical, Exhibition Hall

StephenW

背景/目的：ETV单药治疗的抗病毒效果进行了监测临床在NA有经验的患者在中位随访48个月。
方法：我们调查了恩替卡韦单药治疗的212例慢性乙型肝炎患者在一组研究。 NA-104经验的患者当中，有84人（包括44 LAM耐药）林经验，和58（包括38 ADV耐），ADV经验。抢救治疗（TDF或ADV与ETV）被用于患者反应不佳（定义为HBV-DNA> 500拷贝/ ml的后续2年）ETV或病毒突破。
结果：96％NA初治患者展出VR（HBV-DNA <500拷贝/ ml），而只有68％NA经验的患者表现出VR，而经验NA-13％的患者表现为反应欠佳ETV单药治疗和18％不适用ETV单药治疗经验的患者，中位随访48（6-69）个月期间开发病毒突破。林经验与ETV单药治疗的患者LAM-R表现出显着下降VR比林初治患者（HR = 0.163，P = 0.0013）。然而，ETV的抗病毒疗效没有减少林经验的患者无LAM-R（HR = 0.63，P = 0.584）。 ADV-经验的患者，ETV单药治疗的抗病毒效果不受影响ADV初治患者相比，无论是否ADV-R（HR = 0.58，P = 0.253）或（HR = 0.28，P = 0.52）。接受抢救治疗14例反应欠佳（6 TDF和ADV附加的），和13（93％）患者表现VR期间，中位随访20个月（15-32）。还收到19例病毒突破抢救治疗（9 TDF和ADV附加的），和16（84％）患者表现VR期间，中位随访19个月（16-28）。
结论：ETV的抗病毒疗效，并没有受到影响前的ADV治疗LAM治疗LAM-R没有了后续48个月。 LAM-R的患者表现出较低的VR率比林初治患者。对于未能显示VR ETV单药治疗的患者，共同管理ADV或TDF仍然可以实现VR。

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