The use of peginterferon alone, or in combination with ribavirin, points to a cure for hepatitis C, the leading cause of cirrhosis, liver cancer and the need for liver transplant, a Virginia Commonwealth University researcher said today.
Mitchell Shiffman, M.D., professor in the VCU School of Medicine, and chief of hepatology and medical director of the Liver Transplant Program at the Virginia Commonwealth University Medical Center, is one of the lead investigators in the study, which was presented at the 38th annual Digestive Disease Week conference in Washington, D.C. VCU was among about 40 sites worldwide studying pegylated interferon alfa-2a, manufactured by Roche Inc.
Nearly all -- 99 percent, of patients with hepatitis C who were treated successfully with peginterferon alone, or in combination with ribavirin, had no detectable virus up to seven years later. Researchers say this data validates the use of the word "cure" when describing hepatitis C treatment as successful treatment is defined as having undetectable hepatitis C virus in the blood six months following treatment.
"We at VCU are encouraged by this data because it is rare in the treatment of life-threatening viral diseases that we can tell patients they may be cured," Shiffman said. "In hepatitis C today, we are able to help some patients achieve an outcome that effectively enables them to put their disease behind them."
The results are based on a long-term follow-up study designed to determine if the virus re-emerges in patients who have achieved treatment success. The study reviewed 997 patients, either mono-infected with chronic HCV or co-infected HCV and HIV, who achieved a sustained viral response (SVR) following treatment with either Pegasys (peginterferon alfa-2a) monotherapy or combination therapy with Pegasys and ribavirin.
After successful treatment, researchers monitored serum levels of HCV once a year for an average of 4.1 years (range 0.4 to 7 years). Of the 997 patients, 989 maintained undetectable levels of HCV. The remaining eight patients tested positive for HCV at an average of two years following treatment completion. The study found that these eight patients exhibited no consistency in age, gender or HCV genotype, and it has not yet been determined if these patients experienced a relapse or if they were re-infected with HCV.
Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. According to the Centers for Disease Control and Prevention, an estimated 4.1 million Americans have been infected with hepatitis C, and 3.2 million are chronically infected. The number of new infections per year declined from an average of 240,000 in the 1980s to about 26,000 in 2004, the latest year for which statistics are available. The CDC estimates the number of hepatitis C-related deaths could increase to 38,000 annually by the year 2010, surpassing annual HIV/AIDS deaths.