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http://www.jaypeejournals.com/eJ ... ue=20&isPDF=YES
DISCUSSION
After treatment with HeberNasvac, all patients evi-denced a constant improvement in the virological and serological variables associated with CHB. No reversion in HBe/HBs loss or seroconversion was detected during the 5-year follow-up. The performance of the serologi-cal and biochemical variables was consistent with viral load reductions. Taken together, based on major current guidelines,19-21 none of the patients required additional therapy after treatment with HeberNasvac . The HBeAg-positive patients displayed isolated and transient ALT increases; these flares were followed by strong viral reductions, temporarily associated with HBeAg reduction or loss. Such associations were also described in a larger HeberNasvac phase III CT fol-lowing five IN immunizations.10 ALT flares have been well described during the immune activation related to disease resolution after treatment,22 or spontaneously during the course of the disease.23The patients of the present study, with a documented history of CHB during more than 12 years, incomplete response to a-IFN therapy one decade ago, and several additional complications (comorbidities, alcohol intake and advanced age), exhibited mild fibrosis at the end of follow-up. This slow progression suggests a liver protective role of the therapeutic vaccine, as previously proposed).9 Although the number of patients is limited, the results are consistent with those found in the phase III CT, where the proportion of patients with pre-cirrhosis/cirrhosis was lower after HeberNasvac vaccination com-pared to PegIFN treatment.1
讨论在用HeberNasvac治疗后,所有患者都证实了与CHB相关的病毒学和血清学变量的不断改善。在5年的随访期间未检测到HBe / HBs丢失或血清转换的逆转。血清学和生化变量的表现与病毒载量减少一致。总的来说,基于目前的主要指南,19-21没有患者在用HeberNasvac治疗后需要额外的治疗。 HBeAg阳性患者表现出孤立和短暂的ALT升高;这些突发之后是强烈的病毒减少,暂时与HBeAg减少或丧失有关。此类相关性也在更大的HeberNasvac III期CT中描述,随后进行了5次IN免疫.10在治疗后疾病消退的免疫激活期间,或在疾病过程中自发地,已经充分描述了ALT突发.23目前的研究,记录了超过12年的CHB病史,十年前对α-IFN治疗的不完全反应,以及一些额外的并发症(合并症,酒精摄入和高龄),在随后结束时表现出轻微的纤维化。起来。这种缓慢的进展表明治疗性疫苗的肝脏保护作用,如先前提出的那样。)尽管患者数量有限,但结果与III期CT中发现的结果一致,其中肝硬化前患者的比例/与PegIFN治疗相比,HeberNasvac疫苗接种后肝硬化较低 |
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