Niro Grazia Anna, Ciancio Alessia, Gaeta Giovanni Battista, Smedile Antonina, Marrone Aldo, Olivero Antonella, Stanzione Maria, David Ezio, Brancaccio Giuseppina, Fontana Rosanna, Perri Francesco, Andriulli Angelo, Rizzetto Mario
Gastroenterology CSS Hospital, S.Giovanni Rotondo, and Gastroenterology Molinette Hospital and Unversity, Turin, Italy.
Hepatology. 2006 Sep;44(3):713-20. doi: 10.1002/hep.21296.
Therapy of chronic hepatitis delta with standard interferon therapy has met with limited efficacy. This study was designed to examine the efficacy and safety of peginterferon with or without ribavirin. Thirty-eight serum hepatitis B surface antigen- and HDV RNA-positive patients with alanine aminotransferase (ALT) more than 1.5 times the upper normal limit received peginterferon alpha-2b (1.5 microg/kg) alone as monotherapy (n=16) or in combination with ribavirin (n=22), for 48 weeks. Thereafter, all the patients were maintained on peginterferon for 24 weeks and followed for 24 weeks off therapy. The primary end point studied was the virological and biochemical response at the end of follow-up. HDV RNA was determined by single or nested polymerase chain reaction assays. Twenty-seven patients (71%), 11 receiving monotherapy and 16 receiving the combination treatment, completed the follow-up. At the end of treatment, a virological response was observed in 3 of the patients treated with peginterferon (19%) and in 2 of the patients treated with combination therapy (9%), and a biochemical response was observed in 6 (37.5%) and 9 patients (41%), respectively. In nonresponders, ALT diminished from a mean of 174+/-53 to 86+/-41 IU/L. At the end of follow-up, serum HDV RNA was negative in 8 patients (21%), and a biochemical response was detected in 10 patients (26%). Treatment was discontinued in 25% of the patients, and dosing was modified in 58%. In conclusion, a prolonged course of peginterferon alpha-2b resulted in clearance of serum HDV RNA and ALT normalization in a fifth of patients with chronic hepatitis D, while ribavirin had no effect on the viral clearance rate. Overall tolerance of therapy was poor.
采用标准干扰素疗法治疗慢性丁型肝炎疗效有限。本研究旨在探讨聚乙二醇干扰素联合或不联合利巴韦林的疗效及安全性。38例血清乙肝表面抗原和HDV RNA阳性、丙氨酸氨基转移酶（ALT）高于正常上限1.5倍的患者，单独接受聚乙二醇干扰素α-2b（1.5μg/kg）单药治疗（n = 16）或联合利巴韦林治疗（n = 22），疗程48周。此后，所有患者继续接受聚乙二醇干扰素治疗24周，并在停药后随访24周。研究的主要终点是随访结束时的病毒学和生化反应。HDV RNA通过单链或巢式聚合酶链反应检测。27例患者（71%）完成随访，其中11例接受单药治疗，16例接受联合治疗。治疗结束时，接受聚乙二醇干扰素治疗的患者中有3例（19%）出现病毒学反应，接受联合治疗的患者中有2例（9%）出现病毒学反应；分别有6例（37.5%）和9例（41%）患者出现生化反应。未出现反应的患者中，ALT均值从174±53 IU/L降至86±41 IU/L。随访结束时，8例患者（21%）血清HDV RNA转阴，10例患者（26%）出现生化反应。25%的患者停药，58%的患者调整了剂量。总之，延长疗程的聚乙二醇干扰素α-2b可使五分之一的慢性丁型肝炎患者血清HDV RNA清除、ALT恢复正常，而利巴韦林对病毒清除率无影响。总体治疗耐受性较差。
