New Study Demonstrates Benefits of Hepatitis C Therapy Among Previously Under-Treated Patient Population

RICHMOND, Va. -- New research from the Virginia Commonwealth University Medical Center and other institutions demonstrates hepatitis C patients with normal alanine aminotransferase (ALT) levels benefit from treatment with a combination therapy of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP). Results from this first, international, large-scale study to investigate the use of pegylated interferon in patients with normal ALT levels were presented today at the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston.

"These findings suggest that a large number of hepatitis C patients with normal ALT levels would benefit from Pegasys combination therapy," said Mitchell L. Shiffman, MD, chief of the Hepatology Section and medical director of VCU's Liver Transplant Program, who was a U.S. investigator on the study. "While normally associated with milder liver disease, ALT levels vary from person to person and can fluctuate from month to month. This study provides a great deal more information on how we should treat the 30 percent of chronic hepatitis C patients who have normal ALT levels."

ALT is an enzyme that is released by the liver when it becomes damaged and levels of ALT tend to increase with the degree of liver injury. However, once cirrhosis occurs, levels may or may not be high. Because of a lack of data, there has been no consensus on whether or not patients with chronic hepatitis C and normal ALT levels should receive treatment.

In this study, 30 percent of patients treated for 24 weeks and 52 percent of patients treated for 48 weeks achieved a sustained virologic response (SVR). Sustained virologic response refers to patients in whom the hepatitis C virus remains undetectable 24 weeks after finishing a course of treatment. According to Shiffman, patients with SVR rarely develop recurrent hepatitis C.

For patients with genotype 1, the most difficult to treat strain of the virus and the most common in the United States, 40 percent of patients treated for 48 weeks achieved a SVR. In those patients with genotype 2 or 3 treated for 24 weeks, response rates reached nearly 80 percent. These response rates are similar to those seen in previous Pegasys combination therapy studies conducted in patients with elevated ALT levels.

Recommendations suggest that genotype 1 patients with elevated ALT be treated with 1,000 to 1,200 mg of ribavirin. Patients in this study were treated with 800 mg suggesting that those with normal ALT can be just as successful on treatment with lower doses of ribavirin. Additionally, patients in the control arm that had normal ALT and were not treated did have significant liver disease progression. Data on adverse events was similar to previous studies of pegylated interferon for the treatment of chronic hepatitis C. However, the incidence of the most common adverse events associated with pegylated interferon was lower in patients with normal ALT levels compared to the incidence observed in patients with abnormal or high ALT levels in other studies of Pegasys and Copegus.

The study included 491 patients worldwide that were randomized to three treatment arms: 212 were treated with Pegasys 180 mcg/week and Copegus 800 mg/day for 24 weeks; 210 received the same combination for 48 weeks and 69 patients received no treatment. All patients were monitored for 72 weeks.

Hepatitis C is a bloodborne virus that attacks the liver, causing cirrhosis and liver cancer, and is the primary reason many patients undergo liver transplants in the U.S. An estimated 4 million Americans are chronically infected with the virus, with about 35,000 new infections reported each year. The main risk factors associated with hepatitis C transmission include blood transfusions prior to 1992 and IV drug use. Tattoos and piercings administered with non-sterile equipment may also spread hepatitis C.

The study was funded by a research grant from Roche, the manufacturer of Pegasys and Copegus. Pegasys/Copegus combination therapy was approved by the U.S. Food and Drug Administration (FDA) last December for the treatment of adults with chronic hepatitis C who have stable liver disease and have not previously been treated with interferon alpha.

Source: Virginia Commonwealth University