Clinical Research News

Viramidine for Hepatitis C: A New Therapy Enters the Mix

CREDIT: Nancy Heim

An estimated four million Americans are currently infected with Hepatitis C, a viral disease that forces the liver to swell and prevents it from functioning properly. Hepatitis C-related liver disease is the most common reason for liver transplantation in adults. A multifunctional organ, the liver fights infections and stops bleeding, it removes drugs and other poisons from the bloodstream, and it stores energy for when you need it. Hepatitis C is caused by the Hepatitis C virus (HCV) and is spread by contact with infected blood—typically through sexual transmission and unsafe injection practices.

The Hepatitis C virus mutates frequently, hindering the search for a vaccine to combat the disease. However, Hepatitis C's slowly progressive infection means that infected patients can experience long life expectancies and, with proper treatment, many of them can recover completely. Robert S. Brown Jr., MD, MPH, Associate Professor of Clinical Medicine and Pediatrics at Columbia University College of Physicians & Surgeons and Medical Director of the Division of Abdominal Organ Transplantation at NewYork-Presbyterian Hospital, is fighting to give more Hepatitis C patients a complete recovery through a new clinical trial called Viser 1.

The Viser 1 trial is a phase III randomized, double-blind, multi-center study comparing the standard treatment for chronic Hepatitis C to a new therapy. Currently, chronic Hepatitis C is treated with a drug called Peginterferon, usually in combination with the drug Ribavirin. Ribavirin is an oral antiviral agent that has activity against a broad range of viruses. By itself, Ribavirin has little effect on HCV, but adding it to interferon increases the sustained response rate.

"In the Viser 1 trial, we will be comparing the standard combination therapy (Peginterferon and Ribavirin) to a new combination therapy: Peginterferon and Viramidine. Viramidine is a new Ribavirin compound. Peginterferon and Ribavirin can offer the chance of a cure in about 50-70% of patients based on the patient's HCV genotype, or specific variation of HCV. But one of the major side effects of the current treatment with Ribavirin is anemia (a deficiency of red blood cells that can cause fatigue). Severe anemia may lead to either dose reduction of the Ribavirin, decreasing its efficacy, or early termination of therapy," explains Dr. Brown. "Viramidine differs from the old Ribavirin in that it requires an enzyme in the liver to become active. Hopefully, limiting Viramidine's exposure to the rest of the body will result in a lower occurrence of anemia."

To qualify for the Viser 1 trial, individuals must meet the following inclusion criteria:

Chronic Hepatitis C
No prior treatment for Hepatitis C
Good liver function

Trial participants will receive a year of treatment and six months of followup care.

"Our goal with Viramidine is to provide higher cure rates and to make the treatment safer and more effective. The purpose of this phase of the trial is to test the effectiveness of the drug. Preliminary data from the preceding phase II trial indicated that Viramidine had statistically less anemia associated with it, so we feel we're moving in the right direction here—and that we may indeed have a new treatment on our hands that is better tolerated by patients," says Dr. Brown.

For more information on the Viser 1 trial (IRB # AAAA2565), please contact Dr. Brown at 212.305.0914.