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A new study presented today demonstrates that patients on the liver transplant list with hepatitis C virus (HCV) and severe liver damage were more likely to be taken off the list or have their need of a liver transplant reduced as a result of direct-acting antiviral therapy.
The study, presented at The International Liver Congress™ 2016 in Barcelona, Spain, showed that the condition of 35 percent of these patients improved to such an extent that they were no longer considered in urgent need of a transplant, while 20 percent of the patients no longer required a liver transplant at all.
Severe liver damage, also known as decompensated cirrhosis, is a life threatening condition in which extensive scarring of the liver results in its inability to function properly. The only treatment currently available for decompensated cirrhosis is a liver transplant. Patients with decompensated HCV cirrhosis comprise 30 percent of adults on the liver transplant waiting list. There are over 8,500 people in Europe and more than 15,000 people in the United States waiting for a liver transplant, with this number expected to increase. Furthermore, in the United States approximately 16 percent of patients will die while awaiting a liver transplant.
"The results of the study are very encouraging, but a word of caution is to be mentioned since it is presently unknown how long the clinical improvement will last," said Dr. Luca Belli, of the Gastroenterology and Hepatology Liver Unit at Niguarda Hospital, Milan, Italy and lead author of the study. "In this respect we encourage multi-national observational studies on patients who have been listed for decompensated HCV cirrhosis and subsequently de-listed because of clinical improvement. It is in fact critical to assess the long-term risks of death, further re-deterioration and development of liver cancer more specifically, as all these factors still need to be verified."
The retrospective European study was conducted over one year on 103 liver transplant candidates with decompensated HCV cirrhosis and without hepatocellular carcinoma, the most common type of liver cancer. These patients had been treated with direct-acting antiviral combinations, medicines which have been used to treat and cure almost all patients with HCV.
Patients in the study that no longer urgently required a transplant (n=25) demonstrated, on average, an 11 percent (or four point) decrease in severity of disease based on the Model for End-Stage Liver Disease (MELD) score, a commonly used scale which assesses disease severity and urgency for a liver transplant. These patients also saw a 20 percent (or three point) improvement on the Child-Pugh score, another commonly used scale to assess the prognosis of chronic liver diseases, including cirrhosis.
"These results show notable improvements in the outlook for some of these patients with HCV and decompensated cirrhosis," said professor Laurent Castera, EASL secretary general. "Treating these patients with direct-acting antiviral therapy could result in those with a more pressing need for a liver transplant receiving the donation they need, potentially reducing the number of deaths that occur in patients on the waiting list."
The MELD score is a reliable, numerical measure of mortality risk in patients with end-stage liver disease and helps to prioritize allocation of livers for transplant. The score ranges from 6, for those with less severe disease, to 40, for those who are critically ill. The score determines how urgently someone requires a transplant within three months and takes into consideration results from three routine lab tests, which include bilirubin (a measure of the ability of the liver to excrete bile), the International Normalized Ratio (INR) of Prothrombin Time (a measure of the liver's ability to make blood clotting factors), and creatinine (a measure of kidney function).
The Child-Pugh score is a scoring system to measure the severity of chronic liver disease. The score takes into account bilirubin, INR, serum albumin (a measure of a protein made by the liver), ascites (the accumulation of fluid in the abdomen), and the presence of hepatic encephalopathy (a condition observed in patients with cirrhosis characterized by personality changes, intellectual impairment and depressed levels of consciousness). The Child-Pugh score can range from 5, for those with less severe disease, to 15, for those who are critically ill.
Source: European Association for the Study of the Liver