Dr. Vierling Co-Authors NEJM Article on HCV Treatment
John M. Vierling, M.D., professor of Surgery and Medicine in the Division of Abdominal Transplantation at Baylor College of Medicine, co-authored an article in the June, 2017 issue of the New England Journal of Medicine. It is the first publication on the safety and efficacy of a new triple drug regimen (formulated into a single pill taken once daily) for the treatment of patients who previously failed to achieve a sustained virologic response (SVR, which represents a cure of the HCV infection) after prior treatment with direct-acting antiviral (DAA) agents. Patients who relapse after DAA therapy typically have resistance-associated substitutions (RASs) that confer resistance and defeat attempts to retreat patients successfully. The sponsor is Gilead Sciences, and the three drugs are sofosbuvir (NS5B nucleotide inhibitor), velpatasvir (NS4A replication complex inhibitor) and voxilaprevir (NS3/4A protease inhibitor). The combination is effective against all 6 genotypes of HCV.
Dr. Vierling directs Advanced Liver Therapies at Baylor St. Luke’s Medical Center, a clinical research unit devoted to clinical trials of new diagnostics and therapeutics in adult hepatobiliary diseases. His primary research interests are the immunopathogenic mechanisms involved in hepatobiliary injury caused by viral hepatitis, autoimmunity, alloimmunity, and non-alcoholic fatty liver disease.
Metabolomic Signature of Altered Hemodynamics in Subjects with Cirrhosis
Ayse L. Mindikoglu, M.D., M.P.H., associate professor in the Division of Abdominal Transplantation, was awarded a grant from the MacDonald Fund at Baylor St. Luke’s Medical Center for her proposal, “Metabolomic Signature of Altered Hemodynamics in Subjects with Cirrhosis.” This metabolomics signature may prove valuable for patients with cirrhosis as a predictor of outcomes after successful therapy of hepatorenal syndrome.
Advanced Liver Therapies Research at Baylor St. Luke’s Medical Center
Directed by NIH-funded investigator, John Vierling, M.D., professor of surgery and medicine, Advanced Liver Therapies at Baylor St. Luke’s Medical Center is a clinical research center for liver diseases affiliated with the Baylor College of Medicine. The mission is to conduct Food & Drug Administration (FDA) approved clinical studies designed to advance the science and practice of hepatology and liver transplantation. With over 75 years of combined research experience, ALT staff endorses and practices the highest standards of ethical research, while providing opportunities for all patients to participate in clinical trials.
Emphasizing a “laboratory bench to bedside” philosophy, Dr. Vierling has also been active in the design and execution of clinical therapeutic trials of antiviral agents for treatment of hepatitis B and C infections in patients before and after liver transplantation, and trials of immunosuppressive drugs in liver transplantation and autoimmune liver diseases.
ALT is currently conducting clinical research in the following areas: Hepatitis C, Hepatitis B, Fatty Liver Disease, Hepatic Encephalopathy, Primary Biliary Cirrhosis, Hepatorenal Syndrome, and Anti-Fibrosis. Studies include:
Volixibat (SHP626) in the Treatment of Adults with Nonalcoholic Steatohepatitis (NASH)
Dr. Vierling is the principal investigator of a Phase 2 double-blind, randomized, placebo-controlled dose-finding study (NCT02787304), sponsored by Shire, to evaluate the safety tolerability and efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in adults with nonalcoholic steatohepatitis (NASH).
Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension (ENCORE-PH)
This is a multicenter, randomized, double-blind, placebo-controlled trial (NCT02960204), sponsored by Conatus Pharmaceuticals Inc., involving subjects with NASH cirrhosis and severe portal hypertension. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID. Dr. Vierling is the principal investigator of the Advanced Liver Therapies Site at Baylor St. Luke’s Medical Center site.
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients with Primary Biliary Cholangitis (COBALT)
Sponsored by Intercept Pharmaceuticals, this study (NCT0230811) will assess the effect of OCA compared to placebo, combined with stable standard care on clinical outcomes in patients with primary biliary cholangitis (PBC). If approved, it would be the first new therapy for the disease in nearly 30 years. PBC is a serious, life-threatening, blue acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. This investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. Dr. Vierling is principal investigator.
Using Telemedicine Technology to Improve Quality and Delivery of Community Health Services
In 2014, Baylor St. Luke’s Medical Center launched the telehealth program, Project ECHO (Extension for Community Healthcare Outcomes), with a team of health professionals and partnering primary care providers throughout Texas. Project ECHO, led by Norman L. Sussman, M.D., associate professor in the Division of Abdominal Transplantation and medical director of Project ECHO, aims to enhance medical resources in communities in Texas that currently lack specialized care for patients suffering from illnesses, like hepatitis C or cirrhosis. The project’s videoconference outreach model uses multipoint teleconferencing to enable specialists like Dr. Sussman from university medical centers to connect with community providers in a peer-to-peer format, and uses case-based learning to teach providers to deliver state-of-the-art medical care. Currently, Project ECHO offers telementoring clinics in hepatitis C, hepatitis B, advanced liver disease, infectious disease and cardiology, with plans to expand.