Background Liver disease assessment is a key aspect of chronic hepatitis C virus (HCV) infection pre-treatment evaluation but guidelines differ on the optimal testing modality given trade-offs in availability and accuracy. We compared clinical outcomes and cost-effectiveness of common fibrosis staging strategies. Methods We simulated adults with chronic HCV receiving care at US health centers through a lifetime microsimulation across five strategies: (1) no staging or treatment (comparator), (2) indirect serum biomarker testing (Fibrosis-4 index [FIB-4]) only, (3) transient elastography (TE) only, (4) staged approach: FIB-4 for all, TE only for intermediate FIB-4 scores (1.45–3.25), and (5) both tests for all. Outcomes included infections cured, cirrhosis cases, liver-related deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We used literature-informed loss to follow-up (LTFU) rates and 2021 Medicaid perspective and costs. Results FIB-4 alone generated the best clinical outcomes: 87.7% cured, 8.7% developed cirrhosis, and 4.6% had liver-related deaths. TE strategies cured 58.5%–76.6%, 16.8%–29.4% developed cirrhosis, and 11.6%–22.6% had liver-related deaths. All TE strategies yielded worse clinical outcomes at higher costs per QALY than FIB-4 only, which had an ICER of $12 869 per QALY gained compared with no staging or treatment. LTFU drove these findings: TE strategies were only cost-effective with no LTFU. In a point-of-care HCV test-and-treat scenario, treatment without any staging was most clinically and cost-effective. Conclusions FIB-4 staging alone resulted in optimal clinical outcomes and was cost-effective. Treatment for chronic HCV should not be delayed while awaiting fibrosis staging with TE.

中文翻译：

---

丙型肝炎病毒感染肝病分期的临床和成本效益：一项微观模拟研究


背景：肝病评估是慢性丙型肝炎病毒 （HCV） 感染治疗前评估的一个关键方面，但考虑到可用性和准确性的权衡，指南对最佳检测方式存在差异。我们比较了常见纤维化分期策略的临床结局和成本效益。方法我们通过五种策略的终生微观模拟模拟在美国卫生中心接受护理的慢性 HCV 成人：（1） 无分期或治疗（对照），（2） 间接血清生物标志物检测（仅纤维化 4 指数 [FIB-4]），（3） 仅瞬时弹性成像 （TE），（4） 分阶段方法：FIB-4 适用于所有，TE 仅用于中间 FIB-4 评分 （1.45-3.25），以及 （5） 两者测试适用于所有。结局包括感染治愈、肝硬化病例、肝脏相关死亡、成本、质量调整生命年 （QALY） 和增量成本效益比 （ICER）。我们使用了文献知情的失访率 （LTFU） 和 2021 年 Medicaid 观点和成本。结果 单独使用 FIB-4 产生了最好的临床结果： 87.7% 治愈，8.7% 发展为肝硬化，4.6% 发生肝脏相关死亡。TE 策略治愈了 58.5%-76.6%，16.8%-29.4% 发展为肝硬化，11.6%-22.6% 为肝脏相关死亡。与仅 FIB-4 相比，所有 TE 策略都以更高的每 QALY 成本产生更差的临床结果，与无分期或治疗相比，每 QALY 获得的 ICER 为 12 869 美元。LTFU 推动了这些发现：TE 策略只有在没有 LTFU 的情况下才具有成本效益。在床旁 HCV 检测和治疗的情况下，没有任何分期的治疗在临床上和成本效益最高。结论 单独 FIB-4 分期可产生最佳临床结局，且具有成本效益。在等待 TE 纤维化分期时，不应延迟对慢性 HCV 的治疗。