For many patients with the hepatitis C virus (HCV), direct antiviral agents (DAA) offer a potential cure for the disease. The Food and Drug Administration (FDA) has recently approved two new DAAs, telaprevir and boceprevir, and with that clinicians must now decide who should be the first to receive this treatment. Discussion of this timely topic is now available in the June issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.
The World Health Organization (WHO) estimates up to 170,000 million individuals worldwide are infected with chronic HCV. In the U.S., HCV is the leading cause of liver-related mortality and most common cause for liver transplantation. Medical evidence has shown that for the past ten years response rates to pegylated interferon and ribavirin treatment have been stagnant, with less than half of patients achieving a sustained virologic response. Now with the introduction of new DAA therapy, it is expected to significantly improve virus clearance rates, particularly in patients with genotype 1, compared to the current standard of care.
"The availability of DAA therapy will forever change the landscape of HCV," explains Andrew Aronsohn, M.D., from the University of Chicago Medical center and co-author of the current paper. "We will now be able to cure patients of HCV disease who we were unable to cure in the past." However, as the authors note, the medical breakthrough with DAAs is coupled with resource scarcity and an equitable distribution based upon medical need is essential.
DAA therapy and its promise to improve efficacy has been well publicized for a number of years, prompting clinicians and patients to defer standard care in cases where there was a low risk of HCV progressing to severe liver disease. The authors point out that in one large study of 4084 patients evaluated for HCV therapy with interferon and ribavirin, of those that declined therapy more than half did so in anticipation of more effective therapy.
The advent of DAAs will likely create a surge in requests to initiate treatment given the number of patients who deferred treatment, along with those patients who failed to respond to standard HCV regiments. The authors performed a time analysis study at their institution to understand the time needed to treat patients with DAA therapy. They found that on average, a health care provider could initiate therapy on three patients each week, and at least 500 requests for evaluation of HCV therapy are anticipated during the first few weeks of DAA availability. "Current staffing will be unable to meet the demands of all HCV patients requesting treatment," concluded co-author, Donald Jensen, M.D. "We propose a plan to educate patients and triage therapy to the neediest patients first, thereby fulfilling the moral framework of distributive justice."
"Distributive Justice and the Arrival of Direct Acting Antivirals. Who Should be First in Line?" Andrew Aronsohn and Donald Jensen. Hepatology; Published Online: April 21, 2011 (DOI: 10.1002/hep.24374); Print Issue Date: June 2011.