McEwan Phil, Ward Thomas, Bennett Hayley, Kalsekar Anupama, Webster Samantha, Brenner Michael, Yuan Yong
HEOR Ltd, Singleton Court Business Park, Monmouth, Wales, United Kingdom; Swansea Centre for Health Economics, School of Human & Health Sciences, Swansea University, Wales, United Kingdom.
HEOR Ltd, Singleton Court Business Park, Monmouth, Wales, United Kingdom.
PLoS One. 2015 Jan 30;10(1):e0117334. doi: 10.1371/journal.pone.0117334. eCollection 2015.
Hepatitis C virus (HCV) infection is one of the principle causes of chronic liver disease. Successful treatment significantly decreases the risk of hepatic morbidity and mortality. Current standard of care achieves sustained virologic response (SVR) rates of 40-80%; however, the HCV therapy landscape is rapidly evolving. The objective of this study was to quantify the clinical and economic benefit associated with increasing levels of SVR.
A published Markov model (MONARCH) that simulates the natural history of hepatitis C over a lifetime horizon was used. Discounted and non-discounted life-years (LYs), quality-adjusted life-years (QALYs) and cost of complication management were estimated for various plausible SVR rates. To demonstrate the robustness of projections obtained, the model was validated to ten UK-specific HCV studies.
QALY estimates ranged from 18.0 years for those treated successfully in fibrosis stage F0 to 7.5 years (discounted) for patients in fibrosis stage F4 who remain untreated. Predicted QALY gains per 10% improvement in SVR ranged from 0.23 (F0) to 0.64 (F4) and 0.58 (F0) to 1.35 (F4) in 40 year old patients (discounted and non-discounted results respectively). In those aged 40, projected discounted HCV-related costs are minimised with successful treatment in F0/F1 (at approximately £ 300), increasing to £ 49,300 in F4 patients who remain untreated. Validation of the model to published UK cost-effectiveness studies produce R2 goodness of fit statistics of 0.988, 0.978 and of 0.973 for total costs, QALYs and incremental cost effectiveness ratios, respectively.
Projecting the long-term clinical and economic consequences associated with chronic hepatitis C is a necessary requirement for the evaluation of new treatments. The principle analysis demonstrates the significant impact on expected costs, LYs and QALYs associated with increasing SVR. A validation analysis demonstrated the robustness of the results reported.
丙型肝炎病毒（HCV）感染是慢性肝病的主要病因之一。成功的治疗可显著降低肝脏发病和死亡风险。当前的标准治疗方案实现了40%-80%的持续病毒学应答（SVR）率；然而，HCV治疗格局正在迅速演变。本研究的目的是量化与SVR水平提高相关的临床和经济效益。
使用一个已发表的马尔可夫模型（MONARCH），该模型模拟了丙型肝炎在整个生命周期的自然史。针对各种合理的SVR率，估计了贴现和未贴现的生命年（LYs）、质量调整生命年（QALYs）以及并发症管理成本。为证明所得预测的稳健性，该模型在十项英国特定的HCV研究中得到验证。
QALY估计值范围从纤维化F0期成功治疗者的18.0年到纤维化F4期未治疗患者的7.5年（贴现后）。在40岁患者中，SVR每提高10%，预测的QALY增益范围从0.23（F0）到0.64（F4），贴现和未贴现结果分别为0.58（F0）到1.35（F4）。在40岁人群中，预测的贴现后HCV相关成本在F0/F1期成功治疗时最小化（约300英镑），在F4期未治疗患者中增加到49300英镑。该模型与已发表的英国成本效益研究进行验证，总成本、QALYs和增量成本效益比的R2拟合优度统计分别为0.988、0.978和0.973。
预测与慢性丙型肝炎相关的长期临床和经济后果是评估新治疗方法的必要要求。主要分析表明，SVR增加对预期成本、LYs和QALYs有显著影响。验证分析证明了所报告结果的稳健性。
