From promising clinical trial findings to strategies for addressing disparities in study enrollment, researchers at the University of Miami Miller School of Medicine presented their leading-edge findings at The Liver Meeting, the annual conference of the American Association for the Study of Liver Diseases (AASLD).
“Our faculty and trainees play a leading role in this annual conference, and 2020 was no exception – even with a new virtual format,” said Paul Martin, M.D., professor and chief of the Division of Digestive Health and Liver Diseases, referring to The Liver Meeting Digital Experience on November 13-16. “This year, our researchers and faculty made significant contributions as well.”
The AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease through research that leads to improved treatment options. Dr. Martin will serve on the Governing Board of the AASLD as Councilor-at-Large, effective January 2021, for a three-year term. He also just concluded his five-year term as the editor-in-chief of Liver Transplantation, the official medical journal of the AASLD.
The pipeline for PSC therapies
At The Liver Meeting, Cynthia Levy, M.D., professor of medicine, the Arthur H. Hertz Endowed Chair in Liver Diseases, and associate director of the Schiff Center for Liver Diseases, presented her recent research on primary sclerosing cholangitis (PSC), a chronic liver disease that can progress to cirrhosis and other complications. While there are no approved pharmaceutical treatments for PSC, Dr. Levy cited several ongoing clinical trials at the Schiff Center in her talk, “Pharmacological Management: What is in the Pipeline?”
Dr. Levy also presented a late-breaker poster on the Glimmer clinical trial, which addressed treatment of pruritus in patients with primary biliary cholangitis (PBC). She was an investigator in the double-blind, placebo-controlled trial, which found that 40 mg twice daily of linerixibat, an inhibitor of a bile acid transporter, was effective in reducing moderate to severe itching.
“This is a landmark study addressing a symptom that adversely affects our patients’ quality of life,” she said. “We are excited about this finding and are undertaking further studies based on those positive results.”
Drawing on his research on the hepatitis C virus (HCV), David Goldberg, M.D., associate professor of medicine, presented a study on “Use of HCV Positive Organs in Transplantation.” He has been involved in the clinical trial of organ transplants from donors with HCV, followed by treatment to cure the viral infection.
“This would increase the life-saving supply of kidney, liver, heart and lung donors,” said Dr. Goldberg. “The data suggests outcomes can be good, particularly with earlier drug treatment. However, these transplants need to be done with safeguards in place, and more research is needed on the short- and long-term results.”
Addressing health disparities
Patricia D. Jones, M.D., assistant professor of clinical medicine, presented “Methodologies in Liver Health Disparities Research Presentation: How to Build a Successful Health Disparities Research Program.” She discussed the historical context and why some Blacks and Hispanics may be wary of participating in clinical trials.
“Liver health researchers can use frameworks from other disciplines for reaching out to underserved communities,” she said, noting that best practices include building relationships with neighborhood leaders and establishing advisory boards. “You should also make sure your staff understands the importance of engaging diverse members or the community.”
Dr. Jones also presented a collaborative initiative that has successfully recruited more than 650 participants since 2018. She is a principal investigator in the multidisciplinary observational study, “Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma and Cholangiocarcinoma.”
“Our goal is to collect a uniform set of data regarding chronic liver disease, cirrhosis or cancer,” she said. “We have been collecting samples and gathering data, and plan to disseminate the findings to our participants in easy-to-understand language in the next few months. We want to explain how their data is helping us, and engage them in the process so they can learn more about the research process.”