Since chronic hepatitis C has become mostly 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; 2. patients should be carefully informed, particularly in treatment deferral, and widespread information on these therapies should be implemented; 3. since treatment was proven to be cost-effective, its use is acceptable in respect of the resource macro-allocation. Concerning individual (micro-)allocation 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 arrival of highly effective/ tolerable combination regimens of direct-acting antiviral, profoundly changing the social choices. Our model could nonetheless support future ethical assessment, since the evaluation pertaining ethical domain remains applicable overall.

Sacchini, D., Craxi', L., Refolo, P., Minacori, R., Cicchetti, A., Gasbarrini, A., Camma', C., Spagnolo, A. G., Ethical assessment of hepatitis C virus treatment: The lesson from first generation protease inhibitors, <<DIGESTIVE AND LIVER DISEASE>>, 2015; 47 (5): 351-355. [doi:10.1016/j.dld.2014.11.011] [http://hdl.handle.net/10807/71790]

Ethical assessment of hepatitis C virus treatment: The lesson from first generation protease inhibitors

Sacchini, Dario;Refolo, Pietro;Minacori, Roberta;Cicchetti, Americo;Gasbarrini, Antonio;Spagnolo, Antonio Gioacchino
2015

Abstract

Since chronic hepatitis C has become mostly 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; 2. patients should be carefully informed, particularly in treatment deferral, and widespread information on these therapies should be implemented; 3. since treatment was proven to be cost-effective, its use is acceptable in respect of the resource macro-allocation. Concerning individual (micro-)allocation 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 arrival of highly effective/ tolerable combination regimens of direct-acting antiviral, profoundly changing the social choices. Our model could nonetheless support future ethical assessment, since the evaluation pertaining ethical domain remains applicable overall.
Inglese
Sacchini, D., Craxi', L., Refolo, P., Minacori, R., Cicchetti, A., Gasbarrini, A., Camma', C., Spagnolo, A. G., Ethical assessment of hepatitis C virus treatment: The lesson from first generation protease inhibitors, <<DIGESTIVE AND LIVER DISEASE>>, 2015; 47 (5): 351-355. [doi:10.1016/j.dld.2014.11.011] [http://hdl.handle.net/10807/71790]
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