Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
"G. D'Alessandro" Department of Sciences for Health Promotion and Mother and Child Care, University of Palermo, Palermo, Italy.
Dig Liver Dis. 2015 May;47(5):351-5. doi: 10.1016/j.dld.2014.11.011. Epub 2014 Nov 24.
Since chronic hepatitis C has mostly become curable, issues concerning choice and allocation of treatment are of major concern. We assessed the foremost ethical issues in hepatitis C virus therapy with 1st generation protease inhibitors using the personalist ethical framework within the health technology assessment methodology. Our aim was to identify values at stake/in conflict and to support both the physicians' choices in hepatitis C therapy and social (macro-) allocation decision-making. The ethical assessment indicates that: (1) safety/effectiveness profile of treatment is guaranteed if its use is restricted to the patients subgroups who may benefit from it; (2) patients should be carefully informed, particularly on treatment deferral, and widespread information on these therapies should be implemented; (3) since treatment was proven to be cost-effective, its use is acceptable respecting resource macro-allocation. Concerning individual (micro-) location criteria: (a) criteria for eligibility to treatment should be clearly identified and updated periodically; (b) information on criteria for eligibility/deferral to treatment for specific patients' subgroups should be made widely known. Interferon-based regimens will disappear from use within the next year, with the introduction of highly effective/tolerable combination regimens of direct-acting antivirals, thus profoundly changing social choices. Nonetheless, our model could support future ethical assessment since the evaluation pertaining ethical domains remains generally applicable.
由于慢性丙型肝炎已基本可治愈，因此治疗方案的选择和分配成为主要关注点。我们运用健康技术评估方法中的人格论伦理框架，对第一代蛋白酶抑制剂治疗丙型肝炎病毒的首要伦理问题进行了评估。我们的目的是识别相关利益和冲突，并支持丙型肝炎治疗中的医生选择和社会（宏观）分配决策。伦理评估表明：（1）如果将治疗方法限制在可能从中受益的患者亚组中，就可以保证治疗的安全性/有效性；（2）应仔细告知患者，特别是关于治疗推迟的问题，并应广泛宣传这些治疗方法；（3）由于治疗已被证明具有成本效益，因此在尊重资源宏观分配的前提下，使用该治疗方法是可以接受的。对于个人（微观）定位标准：（a）应明确确定治疗的资格标准，并定期更新；（b）应广泛宣传特定患者亚组治疗资格/推迟治疗的标准信息。随着高效/耐受性直接作用抗病毒药物联合方案的引入，基于干扰素的方案将在一年内消失，这将极大地改变社会选择。然而，我们的模型可以支持未来的伦理评估，因为有关伦理领域的评估仍然具有普遍适用性。
