A recent study published in the journal Hepatology shows that a new combination therapy could effectively treat patients with chronic hepatitis C (HCV) who do not respond to the standard therapy of pegylated interferon (PEG-IFN) and ribavirin (RBV). The new approach uses interferon alfacon-1, also called consensus interferon (CIFN), a synthetic version of interferon, with RBV.
The lead investigator of the study was Bruce Bacon, MD, director of the division of gastroenterology and hepatology at Saint Louis University (SLU) School of Medicine and co-director of the Saint Louis University Liver Center in Missouri.
HCV can cause liver cancer, cirrhosis, end stage liver disease and liver failure. The current therapy is costly, often produces severe side effects and has a significant failure rate. Approximately 50% of chronic HCV patients who go through a cycle of PEG-IFN/RBV therapy, which typically lasts 24 or 48 weeks, are unsuccessful at clearing the virus. They are called “nonresponders.”
The multi-center study, headed by SLU researchers, included 515 nonresponders. The patients, from 44 trial sites, received either one of two doses (a smaller and a larger) of daily CIFN with ribavirin, or no therapy at all.
The results showed that CIFN and RBV were effective in approximately 7% of patients given the lower dose and in about 11% of patients given the higher dose. Investigators reported that the therapy was safe and well tolerated by the patients. In addition, patients exhibiting less severe liver damage characterized by fibrosis (liver scarring) and some response to initial treatment experienced a success rate of more than 30%. “This represents an important advance for difficult to treat hepatitis C patients who have failed to respond to traditional therapy,” said Bacon.
“Retreatment of PEG-IFN and RBV non-responders with CIFN and RBV is safe and efficacious and can be considered a retreatment strategy for patients failing previous therapy with PEG-IFN/RBV, especially in interferon-sensitive patients with lower baseline fibrosis scores,” concluded study authors.
The study was funded by Valeant Pharmaceuticals, a multi-national specialty pharmaceutical company in Orange, CA, and Warrendale, PA-based 3 Rivers Pharmaceuticals.
Source: Bacon B, Shiffman M, Mendes F, et al. Retreating Chronic Hepatitis C with Daily Interferon Alfacon-1/Ribavirin after Nonresponse to Pegylated Interferon/Ribavirin: DIRECT Results. Hepatology, June 2009; 49 (6): 1838-1846.