New combination treatment for hepatitis C may be more effective than standard of care

May 22, 2001

Chapel Hill, NC - New findings from a large international study led by researchers at the University of North Carolina at Chapel Hill suggest that a combination treatment with a new long-acting interferon drug and an antiviral medication may be more effective than the current standard of care for hepatitis C.

The multi-center Phase III clinical trial found a significantly higher sustained viral response rate among hepatitis C patients treated with the investigational drug PEG interferon alfa-2a (Pegasys) in combination with the oral antiviral medication, ribavirin, than among those treated with interferon alfa-2b plus ribavirin (Rebetron), the current standard of care.

Patients treated with the new combination attained a 56 percent sustained response rate (SVR), while those receiving standard care attained a 45 percent SVR. Those on PEG interferon alpha-2a plus placebo attained a 30 percent SVR.

"And sustained response means clearance of the virus with normal liver enzymes six months after the end of treatment, which at that point implies a cure," said Michael W. Fried, MD, Associate Professor of Medicine and Director of Clinical Hepatology at the University of North Carolina Chapel Hill School of Medicine.

Fried presented the results today, May 22, at the plenary session of Digestive Disease Week, the largest international medical meeting in the fields of hepatology and gastroenterology.

"These data go a long way in furthering our understanding of Pegylated interferon alfa-2a," said Fried. "The combination of this drug plus ribavirin was clearly shown to be superior to our standard of care." In his presentation, Fried also discussed data suggesting that response to PEG interferon alpha-2a plus ribavirin is predictable. At week 12, 86 percent of patients treated with PEG interferon will show a viral response; of these, 65 percent will go on to attain a sustained viral response. "This means that physicians can create an alternate treatment plan for patients who do not show any response by week 12," said Fried. "And for those who to respond, it can be a motivation to continue to adhere to their treatment regimens."

Patient tolerance data to the new combination versus tolerability data in the standard treatment were also presented at the plenary session. Investigators found that the most common and troublesome side effects - depression and flu-like symptoms - were less frequent in the PEG interferon alpha-2a plus ribavirin group than in the comparison group. Depression occurred in 21 percent of those taking the new combination, compared with 30 percent in the other group, and 20 percent in the PEG interferon alpha-2a plus placebo arm.

The study was conducted at 81 clinical sites in 18 countries. It involved over 1100 patients in one of three study arms: 453 were treated with PEG interferon alpha-2a plus oral ribavirin; 224, with PEG interferon alpha-2a plus placebo; and 444 with interferon alfa-2b plus ribavirin. Patients were treated for 48 weeks and then monitored for an additional 24 weeks.

Sustained viral response (SVR) was defined as undetectable serum HCV RNA (<50 iu> Sixty-five percent of patients were infected with hepatitis C genotype 1, and 14 percent had cirrhosis, or scarring of the liver. Among those infected with genotype 1, 46 percent of those treated with the new combination (n=298) attained an SVR, as compared to 37 percent of those treated with the standard care (n=285).

"This is the most difficult-to-treat population and the most prevalent genotype in the United States. We are very pleased with this impressive response rate for gentotype 1 in those treated with the PEG interferon alfa-2a combination," Fried said.

The hepatitis C virus (HCV) is a life-threatening viral infection of the liver transmitted primarily through infected blood and blood products. Approximately 2.7 million Americans and 170 million people worldwide are chronically infected with HCV. HCV is often described as "silent" because people may be infected for 10 to 30 years and not exhibit symptoms, yet still be carrying the virus. While many patients with HCV will not develop complications from their liver disease, chronic hepatitis C is still a leading cause of cirrhosis and liver cancer and is the major indication for liver transplants in this country.

The Center for Liver Diseases and Transplantation at the University of North Carolina at Chapel Hill provides highly specialized care for liver diseases for residents of North Carolina and surrounding regions. In addition to its commitment to patient care, the UNC liver program is dedicated to studying novel therapies for viral hepatitis, other chronic liver diseases, and transplantation.
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Media note: contact Dr. Fried at 919-966-2516, mfried@med.unc.edu School of Medicine contact, Leslie Lang, 919-843-9687, llang@med.unc.edu

University of North Carolina Health Care

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