Thursday, July 30, 2009

Study finds competing Hepatitis C treatments offer similar success rates for patients

A new comparative study, led by the DCRI's John McHutchison, MD, found that the leading (and competing) treatments for patients with Hepatitis C are similarly safe and effective for removing detectable levels of the virus in patients.

The study results appeared in the July 22 edition of the New England Journal of Medicine. The DCRI's Andrew Muir, MD, was one of the paper's co-authors. Dr. McHutchison is the director of the DCRI's Gastroenterology and Hepatology Research division.

Approximately 180 million people worldwide have the Hepatitis C virus (HCV), and it is a leading cause of liver disease and liver failure. Treatment guidelines recommend giving patients with HCV who are at high-risk for liver disease either peginterferon alfa-2b or peginterferon alfa-2a (made by different manufacturers), both in combination with the antiviral medication ribavirin. But previously, there have not been many side-by-side comparisons to provide physicians with the evidence-based guidelines they need to best treat their patients.

This new study compares a standard-dose versus a low-dose of peginterferon alfa-2b, with the low-dose patients also receiving ribavirin. The study also looked at the safety and effectiveness of the other recommended treatment, peginterferon alfa-2a plus the antiviral medication, compared to the alfa-2b treatment.

IDEAL (Individualized Dosing Efficacy vs. Flat Dosing to Assess Optimal Pegylated Interferon Therapy) enrolled more than 3000 patients with HCV at 118 sites in the U.S. The patients randomly received one of the three treatment regimens. It is the largest comparative study to date.

Researchers found that patients in all three treatment options had similar rates of having no detectable levels of the virus at the end of the 48-week treatment. The rates of serious complications from treatment were also similar among the three groups of patients.

However, there were significant differences in which group of patients was more likely to have a repeat bout of HCV. “Patients receiving the peginterferon alfa-2a treatment were significantly more likely to relapse, but at this point, we do not know why,” said McHutchison.

Researchers were surprised to find that the low-dose regimen of peginterferon alfa-2b coupled with the ribavirin was so similarly effective at removing detectable levels of the virus. They expected to find a noticeable difference between the standard-dose and the low-dose treatment groups.

The findings could indicate that lowering the dose of peginterferon alfa-2b for certain patients could help manage the often debilitating side effects of treatment without jeopardizing the impact on removing the virus.

The study also provided some information about what treatments could be more successful for women or African-American patients.

“When we evaluated subgroup analyses, we found other interesting findings. For example, it appears that women do significantly better if they receive the standard dose, rather than the low dose of peginterferon alfa-2b. African Americans also tended to do better with the standard dose peginterferon alfa-2b therapy, although the relationship was not statistically significant.”