Individualized Treatment of Hbeag-Negative Chronic Hepatitis B Using Pegylated Interferon-α2A as First-Line and Week-12 HBV Dna/Hbsag Stopping Rule: A Cost-Effectiveness Analysis
Individualized Treatment of Hbeag-Negative Chronic Hepatitis B Using Pegylated Interferon-α2A as First-Line and Week-12 HBV Dna/Hbsag Stopping Rule: A Cost-Effectiveness Analysis
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使用聚乙二醇化干扰素-α2A 作为一线和第 12 周 HBV DNA/Hbsag 停止规则的 Hbeag 阴性慢性乙型肝炎的个体化治疗：成本效益分析
DOI：
10.3851/imp2555
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发表时间：
2013
影响因子：
1.2
通讯作者：
F. Bonino
中科院分区：
文献类型：
--
作者：
S. Iannazzo;B. Coco;M. Brunetto;F. Rossetti;A. Caputo;A. Latour;B. Espinós;F. Bonino
背景：B e抗原（HBeAg）阴性的慢性B型肝炎（CH B）是世界范围内最常见和最难治的病毒性肝炎。HBV DNA和B型肝炎表面抗原（HBsAg）血清水平有助于早期识别对聚乙二醇干扰素（PEG-IFN）无应答者，提示更灵活的个体化治疗策略，利用PEG-IFN和核苷/核苷酸类似物（NAs）的益处。我们评估了第12周HBV DNA/ HBsAg停止规则的成本效益，以早期中断并转换为目前最有效的NA治疗（恩替卡韦[ETV]或富马酸替诺福韦酯[TDF]）。方法建立了一个决策分析马尔可夫模型，包括以下健康相关状态：CHB、代偿性肝硬化（CC）和失代偿性肝硬化、肝细胞癌、肝移植、肝移植后、死亡、病毒学应答、复发和HBsAg清除。模拟战略包括：CHB中的ETV/TDF; ETV/TDF延迟至CC;对于满足第12周停止规则或第48周无效应答者/复发者的患者，一线PEG-IFN随后转换为ETV/TDF;一线PEG-IFN随后转换为ETV/TDF延迟至CC。ETV和TDF被认为是交替的，共八个战略。应用了寿命模拟范围。结果使用NAs联合或不联合一线PEG-IFN的早期治疗策略提供了最高的结果（约22生命年和15质量调整生命年[Qs]）。延迟治疗直到肝硬化发展导致更差的结果。每例患者的平均终生成本范围为33，500欧元（CC中的TDF）至68，900欧元（CHB中的TDF）。使用ETV的成本高出20-50%。一线PEG-IFN策略的范围从占主导地位（即更有效，更便宜），以高度成本效益，虽然差异在QALTS总是非常狭窄。结论对于HBeAg阴性的CHB患者，无论是12周HBV DNA/HBsAg停止治疗的患者还是48周无应答/复发的患者，一线使用PEG-IFN后改用NAs抗病毒治疗的成本-效果均显著提高。
Background Hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) is the most frequent and difficult-to-treat viral hepatitis worldwide. HBV DNA and hepatitis B surface antigen (HBsAg) serum levels, which help the early identification of non-responders to pegylated interferon (PEG-IFN), prompt more flexible individualized therapeutic strategies exploiting the benefits of both PEG-IFN and nucleoside/nucleotide analogues (NAs). We assessed the cost-effectiveness of week-12 HBV DNA/ HBsAg stopping rule for early interruption and switch to currently most effective NA treatments (entecavir [ETV] or tenofovir disoproxil fumarate [TDF]). Methods A decision-analytic Markov model was developed in the following health-related states: CHB, compensated cirrhosis (CC) and decompensated cirrhosis, hepatocellular carcinoma, liver transplant, post-liver transplant, death, virological response, relapse and HBsAg clearance. Simulated strategies included: ETV/TDF in CHB; ETV/TDF delayed until CC; first-line PEG-IFN followed by switch to ETV/TDF for either patients meeting the week-12 stopping rule or week-48 null-responders/relapsers; and first-line PEG-IFN followed by switch to ETV/TDF delayed until CC. ETV and TDF were considered alternatively for a total of eight strategies. A lifetime simulation horizon was applied. Results Early treatment strategies using NAs with or without first-line PEG-IFN provided the highest results (approximately 22 life-years and 15 quality-adjusted life years [QALYs]). Delayed treatments until cirrhosis development resulted in poorer outcomes. The average per-patient lifetime costs ranged from €33,500 (TDF in CC) to €68,900 (TDF in CHB). Costs using ETV were 20–50% higher. First-line PEG-IFN strategies ranged from dominant (that is, more effective and less costly) to highly cost-effective, although differences in QALYs were always very narrow. Conclusions The cost-effectiveness of antiviral therapy of HBeAg-negative CHB could be improved significantly using first-line PEG-IFN followed by a switch to NAs in either patients meeting the week-12 HBV DNA/HBsAg stopping rule or week-48 non-responders/relapsers.
影响因子：
4.5
作者：
Levy, Adrian R.;Kowdley, Kris V.;Briggs, Andrew H.
通讯作者：
Briggs, Andrew H.