1Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: firstname.lastname@example.org.
2"G. D'Alessandro" Department of Sciences for Health Promotion and Mother and Child Care, University of Palermo, Palermo, Italy.
3Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
4Director of Graduate School of Health Economics and Management (ALTEMS), Università Cattolica del Sacro Cuore, Italy.
5Internal Medicine and Gastroenterology Division, Policlinico Gemelli Hospital and Università Cattolica del Sacro Cuore, Rome, Italy.
6Gastroenterology Division, DiBiMIS, University of Palermo, Palermo, Italy.
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.