ACG2016[777]乙型肝炎病毒DNA检测的间歇模式 实现无法检测的

StephenW

ACG2016[777]乙型肝炎病毒DNA检测的间歇模式
  实现无法检测的病毒
级别
Intermittent Pattern of Detection of Hepatitis B Viral DNA After Achieving Undetectable Viral Levels
Michelle C. Tong, MD1, Ira M. Jacobson, MD2.
1. Mount Sinai Beth Israel Medical Center, New York, NY;
2. Mount Sinai Beth Israel Hospital, New York, NY.
Introduction:
  Intermittent  detection  of  hepatitis  B  viral  DNA  after  suppression  to  undetectable  viral level raises concerns about inadequate viral suppression, viral breakthrough, resistance, or noncompliance. This retrospective review was conducted in order to characterize the frequency and clinical significance of this laboratory finding, which will be referred to as intermittency pattern (IP).
Methods:
  Patients  with  hepatitis  B  seen  in  an  outpatient  hepatology  practice  from  April  2015  to  2016 who had been treated or were undergoing treatment with oral nucleos(t)ides were included for review.
Patients  who  did  not  attain  viral  suppression  <  20  IU/ml  by  PCR  amplification  for  quantitative  HBV DNA were excluded.
Results:
A total of 61 patients with HBV were identified. 10 did not require treatment, another 10 did not achieve viral suppression to < 20 IU/ml. The  final study included 41 patients, ranging in age from 33 to 96 years (median 53), 51% female, and HBeAg positive in 27% at time of initiation of therapy. Thirty-eight (93%) were treated with a regimen that included either tenofovir (N=29) or entecavir (N=8) or both
(N=1), the remainder were treated with lamivudine or adefovir (N=3). 83% (N=34) reached undetectable viral load, while the remainder had detectable HBV
DNA but < 20 IU/ ml at nadir. Of these 34 patients,50% (N=17) demonstrated IP, with median of 2 occasions of detectable DNA after reaching undetectable
level. In all of these cases, viral load was < 20 IU/ml but detectable on PCR. None had concurrent elevation in ALT or symptoms at times of viral detectability. In those with IP, median age was 55 years, 58% were female, HBeAg was present in 23%, 6% had cirrhosis, and median time to reach viral suppression < 20 IU/ml was 2 years. In those without IP (N=17) median age was 52 years, 41% were female, HBeAg was present in 29%, and 17% had cirrhosis.
Conclusion:
  50%  of  patients  with  long  term  viral  suppression  demonstrated  IP  by  PCR.  There  was  a  slight  female  predominance  and  fewer  patients  with  cirrhosis  in  patients  with  IP  compared  to  those without.  Possible  explanations  for  the  IP  phenomenon  include  low  level  of  viral  replication  fluctuating  around  the  level  of  detectability  in  patients  whose  virus  is  adequately  suppressed  by  treatment,  
incomplete  medication  compliance,  and  false  positivity  of  the  assay.  Given  that  IP  was  not  associated  with concurrent elevation of ALT, symptoms, or quantifi
able viral level, IP appears to have little clinical significance.

StephenW

ACG2016乙型肝炎病毒DNA检测的间歇模式
  实现无法检测的病毒
级别
间断性模式的乙型肝炎病毒DNA检测后达到无法检测的病毒水平
Michelle C.Tong，MD1，Ira M.Jacobson，MD2。
1.西奈山贝斯以色列医疗中心，纽约，纽约;
2.西奈山贝斯以色列医院，纽约，纽约。
介绍：
  在抑制至不可检测的病毒水平后间歇性检测乙型肝炎病毒DNA引起了对病毒抑制，病毒突破，抗性或不依从性的不充分的担忧。进行该回顾性评价以表征该实验室发现的频率和临床意义，其将被称为间歇性模式（IP）。
方法：
  在2015年4月至2016年在门诊肝病实践中观察到的乙型肝炎患者被治疗或正在接受口服核苷酸（t）治疗。
排除了通过定量HBV DNA的PCR扩增未达到病毒抑制<20 IU / ml的患者。
结果：
共鉴定61例HBV患者。 10不需要治疗，另外10个没有实现病毒抑制至<20IU / ml。最终研究包括41名患者，年龄33-96岁（中位数为53），51％为女性，HBeAg阳性为27％，在开始治疗时。三十八（93％）用包括替诺福韦（N = 29）或恩替卡韦（N = 8）或两者的治疗方案
（N = 1），剩余部分用拉米夫定或阿德福韦（N = 3）治疗。 83％（N = 34）达到不可检测的病毒载量，而其余的具有可检测的HBV
DNA，但在最低点<20 IU / ml。在这34例患者中，50％（N = 17）显示IP，中位数为2次可检测的DNA达到不可检测
水平。在所有这些情况下，病毒载量<20IU / ml，但在PCR上可检测。在病毒可检测性时，没有ALT同时升高或症状。在IP患者中，中位年龄为55岁，58％为女性，HBeAg存在于23％，6％患有肝硬化，达到病毒抑制的中位时间<20 IU / ml为2年。在没有知识产权（N = 17）的人中，中位年龄为52岁，41％为女性，HBeAg存在于29％，17％患有肝硬化。
结论：
  50％长期病毒抑制的患者通过PCR证实为IP。与未患有IP的患者相比，在IP患者中存在轻微的女性优势和较少的肝硬化患者。对IP现象的可能解释包括病毒复制的低水平在病毒通过治疗充分抑制的患者中的可检测性水平附近波动，
不完全药物依从性和测定的假阳性。鉴于IP不与ALT，症状或量化的并发升高相关
能够病毒水平，IP似乎没有什么临床意义。