Arrival of Direct Antiviral Agent Therapy for Hepatitis C Sparks Debate of Who to Treat First

May 31, 2011

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Arrival of Direct Antiviral Agent Therapy for Hepatitis C Sparks Debate of Who

to Treat First

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.

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 Aronsohn, MD, 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, Jensen, MD. " We

propose a plan to educate patients and triage therapy to the neediest patients

first, thereby fulfilling the moral framework of distributive justice. "

Reference: Aronsohn and Jensen. Distributive Justice and the

Arrival of Direct Acting Antivirals. Who Should be First in Line? Hepatology.

June 2011.

May 31, 2011