Published in UAB Insight, Fall 2007
UAB Liver Center Trials for HCV
Hepatitis C virus (HCV) infects an estimated 4 million Americans. Eighty percent of these individuals develop chronic disease, making it the leading cause of liver transplantation.
The cornerstone of care for chronic hepatitis C is the combination of peginterferon alfa-2a/b and ribavirin, which is effective for up to 90% of patients with genotype 2 or 3 HCV and between 40% and 50% of those with genotype 1. HCV has at least six distinct genotypes, which play a significant role in therapeutic decisions.
“Up to 15% of HCV patients cannot tolerate labor-intensive interferon therapy, which is notorious for adverse side effects. Ribavirin adds to that burden, and poor adherence is common,” says UAB hepatologist Michael B. Fallon, MD.
Treatment with combination pegylated interferon and ribavirin may be required for a year or longer. The UAB Liver Center’s clinical trials group is dedicated to finding novel approaches to fine-tune and shorten treatment duration. “Shorter regimens are better tolerated and more likely to result in adherence — a key factor in positive treatment outcomes,” Fallon says. Several clinical trials are underway examining novel small molecules and alternative doses of ribavirin and pegylated interferon. “We are using the latest agents combined with new approaches for patients who are refractory to standard treatment or who have complicating comorbidities, such as HIV or end-stage renal disease,” he says.
Multicenter studies at UAB are assessing the safety and efficacy of various pegylated interferon and ribavirin combinations. Investigators are recruiting patients for a trial evaluating higher doses of peginterferon alfa-2a (Pegasys) or higher ribavirin doses in individuals with genotype 1 to achieve an improved virological response.
A second study compares efficacy and safety of albumin interferon alfa-2b and ribavirin to the current standard of care in treatment naïve patients. Early studies have shown albumin interferon-alfa 2b induces antiviral responses in this population and those refractory to a peginterferon and ribavirin combination. This combination will extend time between doses, increasing regimen convenience.
The Liver Center is enrolling patients in a trial evaluating daily consensus interferon (Infergen) and ribavirin in partial responders or nonresponders to previous interferon therapy. This study is open to HCV monoinfected and HIV coinfected patients.
Liver Center investigators are considering new trials to discover medications for hard-to-treat populations, such as nonresponders and patients with thrombocytopenia, insulin resistance, and HIV. Treatment options for patients with hepatitis B also are a research interest.
Comprehensive Care
Clinical and translational research are key components of UAB’s Liver Center, which offers patients comprehensive care, education, support, and serves as a resource for physicians with patients diagnosed with HCV and other liver diseases.
Current translational research at the Liver Center is limited to the pathogenesis of pulmonary vascular complications of chronic liver disease. In the near future efforts will expand hepatitis C research and will eventually encompass all aspects of liver disease.
For more information:
Dr. Michael Fallon
Dr. Moises Nevah
1.800.UAB.MIST
mist@uabmc.edu