For Medical Professionals - Informed Deferral: A Moral Requirement for Entry Into the Hepatitis C Virus Treatment Warehouse
Posted: February 20, 2013
Provided By:
Donald Hillebrand, MD
Informed Deferral: A Moral Requirement for Entry Into the Hepatitis C Virus Treatment Warehouse
The addition of the first-generation direct-acting antiviral agents (DAAs) to pegylated interferon and ribavirin has offered shorter durations of therapy with increased rates of achieving a sustained virological response (SVR) in genotype 1 chronic hepatitis C infected patients from less than 50% to nearly 75%. This has prompted many individuals to be caught in the 'wait versus treat debate' as future generations of DAA-based treatment promise greater response rates, shorter duration of therapy and better tolerated therapy. The sited editorial published in Hepatology discusses principles of informed consent when it applies to consenting to therapy or consenting to the delay of therapy for Hepatitis C. Informed consent regarding this critical decision of whether a patient will undergo treatment at the present time or defer treatment until these newer regimens are available fits the (subjective standard) model as it will only acknowledge the patient's specific individual needs. Healthcare providers have an obligation to insure that patients understand the risks and benefits of deferral just as they would as if treatment was to be undertaken at the present time. When disclosing informed consent components to individuals contemplating deferral of Hepatitis C treatment there are several limitations that must be acknowledged by the healthcare provider. Liver biopsies have limitations at accurately staging liver disease as there may be sampling error. We have a limited ability to predict progression of fibrosis for individual patients. While the promising agents in the Hepatitis C pipeline are attractive, there is no guarantee when and if they will make it to market. Furthermore, patients may have changes in their insurance status which may be a barrier to their undergoing treatment with these potentially more potent and safer agents in the future. Independent of their liver disease, patients may develop additional comorbidities in their health that make deferring treatment more complicated. Lastly, deferring therapy may put other at risk of contracting the virus for those who are infected and continue to engage in high risk behaviors. With protease inhibitors in combination with pegylated interferon and ribavirin offering a safe and effective therapy selecting treatment deferral is no longer a passive decision but rather is an action in and of itself that requires its own unique consent process and Informed Deferral