title: Ethical assessment of hepatitis C virus treatment: The lesson from first generation protease inhibitors.
abstract: 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.
authors.affiliation: Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: dsacchini@rm.unicatt.it.
authors.forename: Dario
authors.initials: D
authors.lastname: Sacchini
authors.affiliation: "G. D'Alessandro" Department of Sciences for Health Promotion and Mother and Child Care, University of Palermo, Palermo, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Craxì
authors.affiliation: Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Refolo
authors.affiliation: Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Minacori
authors.affiliation: Director of Graduate School of Health Economics and Management (ALTEMS), Università Cattolica del Sacro Cuore, Italy.
authors.forename: Americo
authors.initials: A
authors.lastname: Cicchetti
authors.affiliation: Internal Medicine and Gastroenterology Division, Policlinico Gemelli Hospital and Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Gasbarrini
authors.affiliation: Gastroenterology Division, DiBiMIS, University of Palermo, Palermo, Italy.
authors.forename: Calogero
authors.initials: C
authors.lastname: Cammà
authors.affiliation: Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Antonio G
authors.initials: AG
authors.lastname: Spagnolo
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis / Q000191:economics / Q000941:ethics*; D003657:Decision Making; D004359:Drug Therapy, Combination / Q000941:ethics* / Q000379:methods; D004992:Ethics, Medical; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000472:pathogenicity; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D011480:Protease Inhibitors
keywords: Direct-acting antivirals; Ethics; Health technology assessment; Hepatitis C virus