AASLD-First Study of its Kind Shows that All-oral Treatment Regimen Prevents Hepatitis C Recurrence in Liver Transplant Recipients

Related;
AASLD-Gilead Announces Phase 2 Results for Sofosbuvir-Based Regimens in Hepatitis C Patients Before and After Liver Transplantation

First Study of its Kind Shows that All-oral Treatment Regimen Prevents Hepatitis C Recurrence in Liver Transplant Recipients Who Received Allografts 

For the first time, researchers have been able to prevent the recurrence of hepatitis C virus (HCV) infection in a large proportion of patients (64 percent, n=25/39) who undergo liver transplantation for cirrhosis complicated by hepatocellular carcinoma (HCC). This success was achieved with an interferon-free treatment regimen containing the oral antivirals sofosbuvir, an investigational agent, and ribavirin.

Chronic HCV is the most common indication for liver transplantation. HCV recurrence is universal when a transplant recipient has detectable virus at the time of the procedure. Interferon-based treatments prior to transplantation are poorly tolerated and prevent post-transplant HCV recurrence in only 25 percent of these hard-to-treat patients. Recurrence of HCV can result in accelerated progression to cirrhosis, loss of the graft, and death. 

In a Phase 2 study, 44 patients with chronic HCV who also had cirrhosis and HCC were treated with a combination of sofosbuvir and ribavirin for up to 48 weeks prior to liver transplantation. Of these patients, follow-up was possible for 41 individuals who were HCV undetectable at the time of transplantation. In this group, 25 patients achieved a virologic response (remained HCV undetectable) 12 weeks post-transplant (pTVR12).

Researcher Michael Curry, MD, points out that, "The very high SVR rate is in a population of patients with cirrhosis, predominantly HCV genotype 1, non IL28b CC, and prior treatment failure. This study is the first of its kind to prevent posttransplant HCV recurrence in a large number of patients, most of whom have previously failed prior treatments and could be considered "difficult to treat."

Researchers concluded that the use of an interferon-free, all-oral treatment regimen of sofosbuvir and ribavirin is safe and effective in this challenging patient population. Dr. Curry addressed the subject of retransplantation, "HCV is the most common indication for liver transplantation, and it poses a major problem for transplantation resulting in graft dysfunction, cirrhosis, graft loss, and death or the need for retransplantation. Prevention of HCV recurrence after liver transplant will virtually eliminate the need for retransplantation for this indication and will significantly reduce the resource utilization in transplant units in investigating and treating graft dysfunction in HCV patients."

Abstract title:
Pretransplant Sofosbuvir and Ribavirin to Prevent Recurrence of HCV Infection after Liver Transplantation

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AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Washington, November 2-5, will bring together more than 9,500 researchers from 55 countries. 

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

http://www.aasld.org/livermeeting/press/Pages/curry.aspx