Medical Device Daily Washington Editor

WASHINGTON — The National Institutes of Health (NIH; Bethesda, Maryland) has outlined a plan that could put a new face on liver disease diagnostics. The NIH said its “action plan“ for Liver Disease Research addresses the “burden“ of liver diseases in the U.S. and maps out challenges for future research.

“Over the last 25 years, medical research in liver disease has greatly improved the survival and quality of life of patients with liver disease,“ said Allen Spiegel, MD, director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the NIH unit with lead responsibility for drafting the plan. “This trans-NIH plan summarizes challenges to advancing liver disease research and delineates the major goals for future research.“

A major goal of the plan is to develop standardized and objective diagnostic criteria of major liver diseases and their grading and staging. NIH researchers said that these standards would benefit clinical research on all types of liver disease, including the evaluation of new diagnostic and therapeutic agents.

Another plan objective is to develop non-invasive ways to measure liver fibrosis. Currently, liver biopsy is the standard means of evaluating the severity of liver disease both in clinical practice as well as in clinical trials of new therapies. Availability of reliable and safe means of measuring fibrosis (tissue scarring) and cirrhosis (excessive scarring and destruction of liver structure) would improve management of liver disease and facilitate clinical research, the NIH said.

The research efforts of the NIH also are aimed at developing sensitive and specific means of screening individuals at high risk for early liver cancer. Liver cancer is often fatal and difficult to diagnose at an early stage when it is easier to treat and possible to cure by surgery. Thus, according to Spiegel and his team, “simple and accurate“ diagnostic strategies could detect liver cancer earlier and improve chances for patient survival.

The plan additionally calls for improving the success rate of therapy of hepatitis C and decreasing the mortality rate from liver disease. The currently recommended regimen of antiviral therapy results in long-term viral eradication in only 50% to 60% of hepatitis C patients. The NIH estimates that improved means of prevention and treatment should enable a decrease of at least 20% in the age-adjusted death rates from liver disease in the U.S.

According to the Centers for Disease Control and Prevention (CDC; Atlanta), liver and biliary (gallbladder) disease, including liver cancer, accounts for about 46,000 deaths each year and ranks ninth in overall causes of death.

Currently, about 5,000 liver transplants are performed annually in the U.S. at more than 120 medical centers. As a consequence of the limited supply of livers, there are more than 17,000 patients on the liver transplant waiting list, and at least 1,500 will die annually while waiting, according to the CDC.

“Acute and chronic liver disease affects people of all ages, with the greatest burden among minority individuals and persons between the ages of 40 and 60,“ said Jay Hoofnagle, MD, director of NIDDK's Liver Disease Research Branch. “The major focus of this action plan is to stimulate translation of basic research findings to practical and effective means of prevention and control of liver diseases, including such important conditions as hepatitis B and C, biliary atresia, liver cancer, alcoholic and nonalcoholic fatty liver, primary biliary cirrhosis and autoimmune hepatitis.“

In 2003, the NIH created the Liver Disease Research Branch to focus and accelerate research on liver disease at the NIDDK and to coordinate liver-related research across the NIH and other federal agencies.

“This year-long process was open and inclusive and engaged a great number of scientists and experts in the field of liver disease research,“ Hoofnagle said. “We have highlighted specific goals for the next ten years that are focused upon further reducing the frequency and burden of liver disease.“

A total of 214 research goals identified in the action plan are categorized by their degree of difficulty and timeframe, with several research goals overlapping. The full plan is available online at http://liverplan.niddk.nih.gov.