A Cure for Hepatitis C?
According to Mitchell Shiffman, MD, professor in the Virginia Commonwealth University (VCU) School of Medicine, and chief of hepatology and medical director of the Liver Transplant Program at the VCU Medical Center:
“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. This paper strongly suggests, for the first time, that Hepatitis C is a curable disease. After treatment, 99.6 percent of the patients remained virus undetectable for over five years.”
Shiffman is one of the lead investigators in a study that was presented in May 2007 at the 38th annual Digestive Disease Week conference in Washington, D.C. Virginia Commonwealth University was among about 40 institutions worldwide studying pegylated interferon alfa-2a, manufactured by Roche, Inc.
The results are based on a long-term follow-up study designed to determine if the Hepatitis C virus reemerges in patients who have achieved treatment success. The study reviewed 997 patients, either infected with chronic Hepatitis C or co-infected with Hepatitis C and HIV. Those evaluated had already achieved a sustained virologic response following treatment with either PEGASYS (peginterferon alfa-2a) monotherapy or combination therapy with PEGASYS and ribavirin.
After successful treatment, researchers monitored blood levels of Hepatitis C 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 the virus. Although the remaining eight patients tested positive for Hepatitis C at an average of two years following treatment completion, it is unknown why this occurred. Researchers have not determined if these eight patients experienced a relapse of the virus or if they were re-infected.
Sustained Virologic Response
Virginia Commonwealth University’s results are definitely cause for celebration among those who have persevered through PEGASYS treatment and achieved sustained virologic response (SVR). A course of treatment for Hepatitis C is considered successful when Hepatitis C RNA can no longer be detected in the blood. While Hepatitis C RNA may be undetectable immediately following treatment, this test must be repeated six months later to determine if any of the virus remained and reproduced. When the virus remains undetectable in the blood six months (or more) following Hepatitis C therapy, SVR is considered to be achieved.
The longer a person remains free of the virus, the more convinced health officials are that the person is not just in remission, but is actually cured of Hepatitis C. While most studies following Hepatitis C patients for two to three years after they’ve reached SVR reflect a low relapse rate, the results from VCU cement the notion of a cure. By following and testing Hepatitis C patients with SVR for an average of four years, the realization that SVR is permanent is more believable.
Understanding what VCU’s study results mean to people with Hepatitis C is creating a great deal of confusion.
- What it DOES mean – Those who have achieved SVR with PEGASYS therapy have a 99 percent chance of being cured of Hepatitis C.
- What it DOES NOT mean – Anyone with Hepatitis C can currently be cured.
While the pharmaceutical industry continues to concentrate on new and improved treatments for Hepatitis C, the fact remains that less than half of patients with the most common genotype in the U.S. undergoing PEGASYS treatment attain SVR. According to the manufacturer, two large clinical trials have been conducted to show the effectiveness of PEGASYS with ribavirin combination therapy in patients with Hepatitis C. These studies found, after 48 weeks of unaltered treatment:
- SVR was achieved by 53 percent of participants in one trial and 61 percent in the other.
- Among patients with genotype 1, the most prevalent genotype in the U.S., 44 percent of participants in one trial and 51 percent in the other achieved SVR. For those who had a high viral load, the success rate was even lower – 41 and 47 percent.
The percentage of trial participants achieving SVR does not include those who, due to side effects, dropped out of the study or who had their medication dosages lowered. Again, according to the PEGASYS manufacturer:
- In Hepatitis C monoinfection trials, 11 percent of patients discontinued therapy.
- In Hepatitis C monoinfection trials, 39 percent required modification of therapy.
- In the HCV/HIV coinfection trial, 16 percent of patients discontinued therapy.
- In the HCV/HIV coinfection trial, 39 percent of patients required modification of therapy.
Considering the overall statistics and likelihood of achieving SVR with PEGASYS therapy, the computations demonstrate that people with genotype 1 have approximately a 25 percent chance of being cured. This is because roughly 50 percent of people with Hepatitis C cannot complete the therapy at the full dosage level. Of the 50 percent who complete treatment, about half of those with genotype 1 achieve SVR.
Even though the majority of those who undergo the rigors of PEGASYS therapy do not attain sustained virologic response, the idea that Hepatitis C can be eliminated inspires hope. Now that we know that SVR lasts for four or more years and is likely permanent, researchers will shift their focus on making this cure attainable for everyone infected with Hepatitis C.
www.forbes.com, Study Suggests Cure for Hepatitis C, HealthDay News, Forbes.com, LLC, May 2007.
www.pegasys.com, Effectiveness of PEGASYS (detailed), Hoffman- La Roche, Inc., 2007.
www.pegasys.com, Safety and Tolerability, Hoffman-La Roche, Inc., 2007.
www.sciencedaily.com, Cure For Hepatitis C Announced By Researcher, ScienceDaily, LLC, 2007.
www.terradaily.com, Total Hepatitis C Cure Possible, Ed Susman, United Press International, 2007.