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

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.