National study finds life-threatening barriers in access to breakthrough drugs

Most states violate federal Medicaid law because they deny coverage for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection Program. Taylor's team of researchers examined Medicaid policies for hepatitis C virus treatment using sofosbuvir, more commonly known as Solvadi, and found that most should change policy to improve access to the treatment. The study and its findings were published online in advance of the August issue of the Annals of Internal Medicine.

Hepatitis C virus affects over three million Americans. Worldwide, an estimated 120 to 150 million people have chronic hepatitis C. Left untreated, the infection can lead to cirrhosis, liver failure, and liver cancer. Sofosbuvir is a highly effective pharmaceutical used in combination with other medications to cure the disease.

Taylor's research team, which included the Harvard Law School Center for Health Law and Policy Innovation, Treatment Action Group, Kirby Institute of Australia, and Brown University, found that most Medicaid coverage restrictions for sofosbuvir violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration (FDA) labels.

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Study Identifies Characteristics of Patients Likely to have a Potential Living Liver Donor

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New research published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, reports that younger patients, those who are married, and those with Child-Pugh C disease—the most severe measure of liver disease—are more likely immigrants, divorced patients and those at the lowest income levels [and] were less likely to have a potential live donor volunteer for liver donation.
 
With a limited supply of deceased donor organs, livers from living donors provide a much needed, life-saving option for those with end-stage liver disease. Despite evidence suggesting that the 5-year recipient survival from the time of wait listing is estimated to be 20% higher with a live donor compared with deceased donor, living donor liver transplantation accounts for only a few percent in many Western countries.

“Given that the demand for liver transplantation is greater than the supply of deceased donor organs, there is an interest in increasing live donation at centers with experience in that method of transplantation,” explains lead author Dr. Eberhard Renner with the University Health Network and University of Toronto in Ontario, Canada. “Our study aims to identify recipient characteristics that are associated with having a living donor volunteer for donation.”

The research team reviewed data from 491 patients listed for liver transplantation at the University transplant center over a 24-month period. There were 245 patients identified who had a least one potential living donor with 70% of these recipients being male and having an average age of 53 years at wait listing. Hepatitis C, alcoholic liver disease and hepatocellular carcinoma were listed as reason for liver transplant in 34%, 20%, and 35% of cases in the study group.

Analyses found that recipients who had potential access to a living donor were more likely to have more severe liver disease (Child-Pugh C). The recipients were less likely to be older, single, divorced, immigrants or from the lowest income levels. Commenting about the findings Dr. Renner says, “More research is needed to understand and overcome the barriers to live donor liver transplants. Possible interventions like financial assistance and educational programs may help increase liver donation from living donors.”

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Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.) Full citation: "Recipient Factors Associated with Having a Potential Live Liver Donor.” Adam Doyle, Rania N. Rabie, Arastoo Mokhtari, Mark Cattral, Anand Ghanekar, David Grant, Paul Greig, Gary Levy, Leslie Lilly, Ian McGilvray, Markus Selzner, Nazia Selzner and Eberhard L. Renner. Liver Transplantation; (DOI: 10.1002/lt.24148).

URL: http://doi.wiley.com/10.1022/lt.24148
Author Contact: Media wishing to speak with Dr. Renner may contact Alexandra Radkewycz with Toronto General Hospital, University Health Network at Alexandra.Radkewycz@uhn.ca.

About the Journal
Liver Transplantation is published by Wiley on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AASLD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit http://wileyonlinelibrary.com/journal/lt.

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