Ko Soon Young, Choe Won Hyeok, Kwon So Young, Kim Jeong Han, Seo Jung Woong, Kim Kyun-Hwan, Lee Chang Hong
Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Scand J Gastroenterol. 2012 Nov;47(11):1362-7. doi: 10.3109/00365521.2012.719927. Epub 2012 Aug 31.
Partial virologic response (PVR) in chronic hepatitis B (CHB) patients during antiviral therapy is associated with an increased risk of occurrence of viral resistance and treatment failure. The aim of this study was to evaluate the clinical and virological responses of partial responders to long-term entecavir (ETV) monotherapy.
In this open-labeled prospective study, 128 treatment-naïve CHB patients treated with 0.5 mg ETV once daily for more than 12 months were monitored at baseline and at 3-month intervals during treatment.
At baseline, the mean age of subjects was 47.0 ± 13.0 years, and the median duration of treatment was 27 months; 85 subjects (66.4%) were HBeAg-positive, and 47 patients (36.7%) had liver cirrhosis. Eighteen of 128 patients (14.0%) showed PVR to 48 weeks of ETV treatment, and 13 patients were followed up for over 24 months. Among them, 9 of 13 patients (69.2 %) achieved a complete virologic response (VR, HBV-DNA < 60 IU/mL) during prolonged ETV treatment. Four showed persistent PVR, but only one patient with poor compliance developed genetic resistance to ETV at month 27. The occurrence of PVR was independently associated with a high viral load, more than 7 log(10) IU/mL (p = 0.014).
CHB patients with a high viral load, more than 7 log log(10) IU/mL, are related to the occurrence of PVR during ETV monotherapy. Long-term ETV monotherapy may be effective for suppressing serum HBV DNA levels in treatment- naïve CHB patients with a PVR to ETV.
慢性乙型肝炎（CHB）患者在抗病毒治疗期间的部分病毒学应答（PVR）与病毒耐药和治疗失败风险增加相关。本研究旨在评估部分应答者接受长期恩替卡韦（ETV）单药治疗的临床和病毒学应答情况。
在这项开放标签的前瞻性研究中，对128例初治CHB患者给予0.5mg ETV每日一次治疗超过12个月，在基线及治疗期间每3个月进行监测。
基线时，受试者平均年龄为47.0±13.0岁，中位治疗时间为27个月；85例受试者（66.4%）HBeAg阳性，47例患者（36.7%）有肝硬化。128例患者中有18例（14.0%）在ETV治疗48周时出现PVR，13例患者随访超过24个月。其中，13例患者中有9例（69.2%）在延长的ETV治疗期间实现了完全病毒学应答（VR，HBV-DNA<60IU/mL）。4例表现为持续PVR，但只有1例依从性差的患者在第27个月出现对ETV的基因耐药。PVR的发生与高病毒载量独立相关，病毒载量超过7 log(10)IU/mL（p = 0.014）。
病毒载量超过7 log(10)IU/mL的CHB患者与ETV单药治疗期间PVR的发生有关。长期ETV单药治疗可能对初治CHB患者中对ETV有PVR的患者抑制血清HBV DNA水平有效。
