Hep C Drug Combo for Difficult Cases
New Interferon Dosing Gives Those With Liver Damage New Hope
Nov. 8, 2002 (Boston) -- Patients with liver damage from the hepatitis C virus who fail treatment may be able to get a new lease on life, thanks to an aggressive treatment that uses an old standby drug in a new way, say German researchers.
Stephan Kaiser, MD, and colleagues from the University of Tubingen, Germany, studied 120 people with liver damage from hepatitis C. At the start of the study, all of the patients were thought to be "non-responders," meaning that they had not benefited from standard treatment with interferon and ribavirin. In addition, most of the patients had a form of the disease -- type 1 -- that is notoriously hard to treat and had many other risk factors that made them unlikely to respond to traditional treatment.
However, when these patients were treated with a daily rather than three-day-a-week course of high-dose interferon, followed by additional treatment with interferon and the drug ribavirin for six months, nearly two-thirds of the patients had no detectable virus in the bloodstream. The research was presented at the American Association for the Study of Liver Diseases meeting.
"This is a remarkable study because it really backdates history," says Elizabeth Fagan, MD, who was not involved in the study but has been researching interferon-based therapies for the past two decades. "These patients would be discriminated against for being poor responders. ... These are patients who are doomed to failure on the current regimes that are being talked about." She is professor of pediatrics and internal medicine at Rush Children's Hospital and Rush-Presbyterian St. Luke's Medical Center in Chicago.
According to the National Institutes of Health, nearly 4 million Americans are infected with the hepatitis C virus, with nearly 3 million having long-lasting infections. The virus is thought to account for 10,000 to 12,000 deaths in the U.S. each year, the majority of them from liver disease.
In previous studies, retreatment of patients who fail to respond to conventional therapy with interferon (which helps to boost the immune system) and ribavirin (which attacks viruses) has been effective in less than 10% of patients. But more recent studies using a modified form of interferon, called "consensus interferon," or CIFN, show greater benefits than with the standard form of the drug.
In the German study, each patient was treated with either high-dose or low-dose CIFN.
After the first six weeks, 40% of patients who received the smaller dose had undetectable blood levels of the virus, compared with 60% of patients in the high-dose group. After six months of the combination CIFN and ribavirin therapy, nearly 75% of all patients in the high-dose group had no evidence of infection in the blood.
"I think there are two major points to this study," Kaiser, head of the liver outpatient department and lecturer in hepatology at the University of Tubingen, tells WebMD. "One is that we continue to keep the patients on daily dosing. ... The other point is that we start with a considerably higher dose of interferon." -->