Lamers Mieke H, Kirgiz Özlem Özentürk, Heidrich Benjamin, Wedemeyer Heiner, Drenth Joost P H
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
Antivir Ther. 2012;17(6):1029-37. doi: 10.3851/IMP2306. Epub 2012 Aug 15.
Hepatitis delta virus (HDV) infection therapy is unclear. This systematic analysis aimed to clarify the evidence on the efficacy of interferon (IFN)-α-based therapy in HDV.
We performed a systematic search on electronic databases including MEDLINE (1970 to January 2011), Web of Science, The Cochrane Library and ClinicalTrials.gov. Randomized clinical trials (RCTs) comparing IFN-α-based therapy with either another drug, placebo or no intervention were included. We excluded paediatric studies. We calculated relative risks (RRs) for comparison of treatment options on the primary outcome measure, which was defined as undetectable levels of HDV RNA and normal alanine aminotransferase at end of treatment (EOT; 1 year).
Nine RCTs were included. Seven trials evaluated the treatment with IFN-α (n=132). The remaining two trials evaluated treatment with pegylated (PEG)-IFN-α (n=45). We found that 1-year treatment with high-dose IFN-α achieved better primary outcome rates than with PEG-IFN-α (RR=4.14, 95% CI 1.00, 17.14). Data for 1-year treatment with low-dose IFN-α compared with PEG-IFN-α were similar (RR=2.83, 95% CI 0.65, 12.40), as were low-dose IFN-α versus high-dose IFN-α (RR=0.68, 95% CI 0.31, 1.50). High-dose IFN-α and PEG-IFN-α reached similar HDV RNA suppression 24 weeks after EOT (RR=1.00, 95% CI 0.51, 1.97). None of the 55 patients assigned to no intervention obtained undetectable levels of HDV RNA and only one patient achieved normalization of alanine aminotransferase level.
Based on available RCTs, 1-year high-dose IFN-α monotherapy appears to be more effective than PEG-IFN-α for treatment of HDV patients, with efficacy rates of approximately 30%. There is a lack of head-to-head comparisons. Combination therapies and longer treatment duration need to be investigated.
丁型肝炎病毒（HDV）感染的治疗尚不清楚。本系统分析旨在阐明基于干扰素（IFN）-α治疗HDV的疗效证据。
我们在包括MEDLINE（1970年至2011年1月）、科学引文索引、考克兰图书馆和临床试验.gov在内的电子数据库中进行了系统检索。纳入了比较基于IFN-α治疗与另一种药物、安慰剂或无干预措施的随机临床试验（RCT）。我们排除了儿科研究。我们计算了治疗方案在主要结局指标上的相对风险（RR），主要结局指标定义为治疗结束时（EOT；1年）HDV RNA检测不到且丙氨酸转氨酶正常。
纳入了9项RCT。7项试验评估了IFN-α治疗（n = 132）。其余2项试验评估了聚乙二醇化（PEG）-IFN-α治疗（n = 45）。我们发现，高剂量IFN-α治疗1年的主要结局率优于PEG-IFN-α（RR = 4.14，95%CI 1.00，17.14）。低剂量IFN-α与PEG-IFN-α治疗1年的数据相似（RR = 2.83，95%CI 0.65，12.40），低剂量IFN-α与高剂量IFN-α的数据也相似（RR = 0.68，95%CI 0.31，1.50）。高剂量IFN-α和PEG-IFN-α在EOT后24周达到相似的HDV RNA抑制水平（RR = 1.00，95%CI 0.51，1.97）。分配至无干预措施的55例患者中，无一例HDV RNA检测不到，仅1例患者丙氨酸转氨酶水平恢复正常。
基于现有RCT，1年高剂量IFN-α单药治疗对HDV患者的治疗效果似乎优于PEG-IFN-α，有效率约为30%。缺乏直接比较。联合治疗和更长的治疗持续时间需要进一步研究。
