Department of Medicine, Liaquat University of Medical and Health Sciences, Jamshoro/Hyderabad 71000, Pakistan.
World J Gastroenterol. 2012 Oct 28;18(40):5793-8. doi: 10.3748/wjg.v18.i40.5793.
To observe the efficacy of peg-interferon in the treatment of hepatitis delta virus (HDV) and to identify the factors that would be predictive of the sustained viral response (SVR).
This prospective study was conducted in Medical Unit IV of the Liaquat University of Medical and Health Sciences Hospital Jamshoro from June 2008 to September 2011. This study cohort included all patients of either sex who presented during this time with hepatitis B surface antigen positivity, hepatitis B virus DNA > 20,000 IU/mL, serum glutamic pyruvic transaminase (SGPT) > 2(upper limit of normal), HDV-RNA positivity with fibrosis stage ≥ 2. Informed consent was obtained from each of these individuals. Patients were diagnosed with hepatitis D on the basis of detectable viral antibodies and the presence of HDV-RNA in their serum. A liver biopsy was performed in all cases and fibrosis staging was performed in accordance with the METAVIR scoring system. All eligible patients were administered peg-interferon at a weekly dosage of 1.5 μg/kg body weight for 48 wk. HDV-RNA was assayed at the end of this treatment period and again at 24 wk later. A biochemical response was determined by a normalization of SGPT at the end of the treatment or during follow up. The end of treatment response was defined by a HDV-RNA negative status. A sustained virological response was defined by undetectable serum HDV-RNA at six months after the end of treatment.
Among the 277 patients enrolled in our present study, 238 completed a course of peg-interferon therapy of which 180 (75.6%) were male and 58 (24.4%) female. Biochemical responses were achieved in 122/238 (51.3%) patients. End of treatment responses were achieved in 71/238 (29.8%) cases. A SVR was achieved in 70 of these patients (29.4%). A strong association was found between the SVR and the end of treatment responses (P = 0.001), biochemical responses (P = 0.001) and the degree of fibrosis (P = 0.002).
Peg-interferon therapy can induce remission in nearly one third of patients harboring HDV.
观察聚乙二醇干扰素治疗乙型肝炎 delta 病毒(HDV)的疗效,并确定预测持续病毒应答(SVR)的因素。
本前瞻性研究于 2008 年 6 月至 2011 年 9 月在信德医科大学医院医学四科进行。本研究队列包括在此期间出现乙型肝炎表面抗原阳性、乙型肝炎病毒 DNA > 20,000 IU/mL、血清谷氨酸丙酮酸转氨酶(SGPT)> 2(upper limit of normal)、HDV-RNA 阳性且纤维化分期≥2 的所有男女患者。从每位患者获得知情同意。根据可检测的病毒抗体和血清中 HDV-RNA 的存在,这些患者被诊断为乙型肝炎 D。所有患者均进行了肝活检,并按照 METAVIR 评分系统进行纤维化分期。所有符合条件的患者每周接受 1.5μg/kg 体重的聚乙二醇干扰素治疗 48 周。在治疗结束时和 24 周后检测 HDV-RNA。通过治疗结束或随访期间 SGPT 正常化来确定生化反应。治疗结束时的反应定义为 HDV-RNA 阴性。持续病毒学应答定义为治疗结束后 6 个月时血清 HDV-RNA 不可检测。
在我们目前的研究中,277 名患者中,有 238 名完成了聚乙二醇干扰素治疗疗程,其中 180 名(75.6%)为男性,58 名(24.4%)为女性。122/238(51.3%)名患者实现了生化反应。71/238(29.8%)例患者达到了治疗结束时的反应。这些患者中有 70 例(29.4%)实现了持续病毒学应答。SVR 与治疗结束时的反应(P = 0.001)、生化反应(P = 0.001)和纤维化程度(P = 0.002)之间存在很强的关联。
聚乙二醇干扰素治疗可诱导近三分之一携带 HDV 的患者缓解。