恩替卡韦长期治疗免疫功能低下儿童的乙型肝炎安全有效。
Entecavir is Safe and Effective in Long Term for the Treatment of Hepatitis B in Immunocompromised Children.
作者信息
Wani Manzoor A, Sodhi Jaswinder S, Zargar Showkat A, Yatoo Ghulam N, Shah Altaf, Aziz Sheikh A, Geelani Sajad, Haq Inaamul, Gulzar Ghulam M, Khan Mushtaq, Haq Inaamul
机构信息
Gastroenterology and Hepatology, Jawahar Lal Nehru Memorial Hospital(JLNMH), Rainawari, Srinagar, J&K, India.
Department of Gastroenterology and Hepatology, Sheri Kashmir Institute of Medical Sciences(SKIMS), India.
出版信息
J Clin Exp Hepatol. 2020 Mar-Apr;10(2):150-154. doi: 10.1016/j.jceh.2019.04.002. Epub 2019 Apr 18.
OBJECTIVE
Hepatitis B infection is common in patients with cancer, and prompt treatment is necessary; otherwise, it can result in life-threatening complications. The objective of this study was to assess the long-term safety and efficacy of entecavir in immunocompromised children with hepatitis B.
METHODS
This single-center prospective study was conducted on children with different malignancies referred to our department with evidence of hepatitis B infection. Only those children were included in the study who had HBsAg positive and alanine aminotransferase (ALT) more than 2 times the upper limit of normal and whose hepatitis B virus (HBV) DNA was more than 20,000IU/ml. These children were put on entecavir and prospectively observed upto 192 weeks. Primary efficacy end point was the proportion of patients who achieved undetectable HBV DNA at 48 weeks of treatment. Other efficacy end points were the proportion of patients with HBeAg seroconversion, undetectable HBV DNA, and ALT normalization at weeks 48 and 96 weeks.
RESULTS
A total of 41 children met the inclusion criteria, of which 5 children died because of malignancy and 5 were lost to follow-up. Mean log DNA was 7.67 at the start which after starting entecavir reduced to 4.1, 2.8, 1.19, 1.09, and 0.84 at 12, 24, 48, 72, and 96 weeks, respectively ( value < 0.0001). Mean ALT decreased from 332.5 which reduced to 190, 115, 63, and 46 at 4, 12, 24, and 48 weeks, respectively ( < 0.0001). 67.7% achieved the primary outcome and had undetectable DNA at 48 weeks which increased to 26 (83.9%) at 96 weeks. At 48 weeks, 80.6% patients achieved ALT normalization. Thirty percent developed HBeAg seroconversion. Two patients developed virological breakthrough, one at 96 weeks and another at 192 weeks. No significant adverse effects were observed.
CONCLUSION
Entecavir is safe and effective in long term for the treatment of hepatitis B in immunocompromised children.
目的
乙型肝炎感染在癌症患者中很常见，需要及时治疗；否则，可能会导致危及生命的并发症。本研究的目的是评估恩替卡韦对免疫功能低下的乙型肝炎儿童患者的长期安全性和疗效。
方法
本单中心前瞻性研究针对因乙型肝炎感染证据转诊至我科的患有不同恶性肿瘤的儿童进行。仅纳入那些乙肝表面抗原（HBsAg）阳性且丙氨酸氨基转移酶（ALT）超过正常上限2倍且乙肝病毒（HBV）DNA超过20,000IU/ml的儿童。这些儿童接受恩替卡韦治疗，并进行前瞻性观察长达192周。主要疗效终点是治疗48周时实现HBV DNA检测不到的患者比例。其他疗效终点是48周和96周时HBeAg血清学转换、HBV DNA检测不到以及ALT正常化的患者比例。
结果
共有41名儿童符合纳入标准，其中5名儿童因恶性肿瘤死亡，5名失访。开始时平均log DNA为7.67，开始使用恩替卡韦后，在12、24、48、72和96周时分别降至4.1、2.8、1.19、1.09和0.84（P值<0.0001）。平均ALT从332.5分别降至4、12、24和48周时的190、115、63和46（P<0.0001）。67.7%的患者达到主要结局，48周时DNA检测不到，96周时增至26例（83.9%）。48周时，80.6%的患者ALT恢复正常。30%的患者出现HBeAg血清学转换。两名患者出现病毒学突破，一名在96周，另一名在192周。未观察到明显不良反应。
结论
恩替卡韦对免疫功能低下的乙型肝炎儿童患者长期治疗安全有效。
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