Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
J Viral Hepat. 2013 Apr;20 Suppl 1:52-7. doi: 10.1111/jvh.12064.
The aim of this study was to investigate the efficacy of sequential use of telbivudine in hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients with partial responses to pegylated interferon. Patients with partial responses to 48 weeks of pegylated interferon treatment were divided into two groups. In group A, patients stopped pegylated interferon directly without sequential treatment. In group B, patients received sequential treatment with telbivudine 600 mg/day. HBeAg, HBeAb, hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) and creatine kinase levels were determined at baseline and at weeks 12, 24, 36 and 48. Responses and safety were assessed after 48 weeks of telbivudine treatment. Thirty-six patients were recruited. Eighteen of these patients stopped pegylated interferon without sequential treatment (group A). After 48 weeks of follow-up, five patients (28%) had undergone HBeAg seroconversion, nine patients (50%) had undetectable levels of HBV DNA, and 11 patients (61%) achieved normal alanine aminotransferase (ALT) levels. The other 18 patients received sequential telbivudine treatment (group B). After 48 weeks of treatment, 11 patients (61%) had undergone HBeAg seroconversion, and all patients had undetectable levels of HBV DNA and normal ALT levels. All patients tolerated sequential telbivudine treatment, and only slightly elevated creatine kinase levels were observed. Switching to telbivudine therapy was efficient and safe in HBeAg-positive chronic hepatitis B patients with partial responses to 48 weeks of pegylated interferon. Sequential treatment with telbivudine resulted in an HBeAg seroconversion rate of 61% and an HBV DNA loss rate of 100% after 48 weeks. This promising strategy warrants further investigation.
本研究旨在探讨拉米夫定序贯治疗对聚乙二醇干扰素治疗 48 周部分应答的 HBeAg 阳性慢性乙型肝炎患者的疗效。对聚乙二醇干扰素治疗 48 周部分应答的患者分为两组，A 组患者直接停用聚乙二醇干扰素，不进行序贯治疗；B 组患者则接受拉米夫定 600mg/d 序贯治疗。分别于基线、12、24、36 和 48 周检测 HBeAg、HBeAb、乙型肝炎病毒（HBV）DNA、丙氨酸氨基转移酶（ALT）和肌酸激酶水平。拉米夫定治疗 48 周后评估应答和安全性。共纳入 36 例患者，其中 18 例患者未行序贯治疗即停用聚乙二醇干扰素（A 组），随访 48 周后，5 例（28%）患者发生 HBeAg 血清学转换，9 例（50%）患者 HBV DNA 不可测，11 例（61%）患者 ALT 恢复正常。另外 18 例患者接受拉米夫定序贯治疗（B 组），治疗 48 周后 11 例（61%）患者发生 HBeAg 血清学转换，所有患者 HBV DNA 均不可测且 ALT 恢复正常。所有患者均耐受拉米夫定序贯治疗，仅出现轻微肌酸激酶水平升高。聚乙二醇干扰素治疗 48 周部分应答的 HBeAg 阳性慢性乙型肝炎患者换用拉米夫定治疗有效且安全，序贯拉米夫定治疗 48 周后 HBeAg 血清学转换率为 61%，HBV DNA 丢失率为 100%。这种有前景的策略值得进一步研究。
