High Demand for New HCV Drugs Could Cause Ethical Problems

Jim Kling

May 27, 2011 — Earlier this month, the US Food and Drug Administration approved the drugs boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex) for the treatment of hepatitis C virus (HCV) infection. The approvals are good news for patients with HCV, but high patient demand could lead to scarcity and ethical challenges for treatment providers, according to a viewpoint article published in the June issue of Hepatology.

HCV is responsible for 120 million infections worldwide and is a leading cause of liver failure mortality, explain authors Andrew Aronsohn, MD, and Donald Jensen, MD, from the Center for Liver Disease, Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medical Center, Illinois. Pegylated interferon and ribavarin have had some effect, but less than half of patients with HCV achieve a sustained virologic response.

Clinical trial results suggest telaprevir and boceprevir will achieve marked improvement in sustained virologic responses in genotype 1 patients compared with current standard of care therapy.

Some patients who are at low risk for near-future progression have deferred therapy in anticipation of the arrival of these drugs. A recent Veterans' Administration study revealed that 50.3% of patients who refused treatment with interferon and ribavirin did so in anticipation of more effective drugs.

These patients will add to the demand for the drugs, complicating efforts to monitor and educate patients, which is already challenging because treatment regimens are complex. In addition, it could place undue demand on healthcare providers. The authors conducted a time analysis study at their own institution and found that the average healthcare provider could initiate treatment in 3 patients with HCV in a week. They anticipate receiving 500 new patients in the weeks after approval of the new drugs.

This situation, if widespread, could lead to scarcity and inequitable distribution of the drugs. Historically, as in the cases of penicillin, insulin, and other new medical developments that were initially scarce, this has led to inequitable and unjust distribution patterns.

Dr. Aronsohn and Dr. Jensen propose a needs-based solution to the dilemma. Highest priority would be given to the sickest patients, and the remaining patients could be prioritized based on need, starting with cirrhotic patients and ending with asymptomatic F0 to F2 patients. Patients could be educated about the need for providing therapy to the most ill patients and informed that waiting for therapy is safe for patients with early-stage disease.

The authors have disclosed no relevant financial relationships.

Hepatology. 2011;6:1789-1791. Abstract

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