my personal edition > hepatitis c > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Sustained Virological Response Achieved With Weight-Based Ribavirin in Combination Therapy for Treatment-Naive Patients With Chronic Hepatitis C: Presented at AASLD

By Maria Bishop

BOSTON, MA -- November 1, 2006 -- Treatment-naive patients with chronic hepatitis C virus (HCV) genotype 2 appear to have excellent sustained virologic responses (SVR) to a combination of pegylated interferon alfa-2b 1.5 mcg/kg/week and body-weight-based ribavirin, researchers reported here at the 57^th Annual Meeting of the American Society for Liver Diseases (AASLD).

It has been suggested that obese patients with hepatitis C virus (HCV) have more rapid progression of liver disease and lower rates of response to antiviral therapy compared with nonobese patients.

However, the interim results of the Canadian POWeR (Pegetron Prospective Optimal Weight-Based Dosing Response) program revealed excellent SVRs across all weight categories, despite poor prognostic characteristics, because of the use of weight-based ribavirin.

The POWeR program's lead investigator -- Paul Marotta, MD, FRCPC, medical director of liver transplantation, London Health Sciences Center, London, Ontario, Canada -- presented the findings at the AASLD meeting on October 28^th.

In the large open-label, community-based study, 2,194 patients were enrolled between December 2002 and August 2005. They did not conform to any inclusion/exclusion criteria, and were managed by individual physicians at 138 centers across Canada. Many had poor prognostic characteristics, such as advanced fibrosis (35%); 58% of patients with genotype 1 (G1) had high viral load.

A computer analysis examined the study patients for whom both final end-of-treatment and sustained virologic response data were available. A separate outcomes analysis examined patients with completed and queried case-report forms (including those who discontinued and who were nonresponders).

Even with the poor prognostic indicators of these subjects, response rates for G1 patients were 52% and 42% in the computer and outcomes analyses, respectively. G2 patients exhibited the highest rates, with 87% and 80%, respectively. Response rates in G3 patients were 80% and 72%, respectively.

Relapse rates were calculated using the same patients for whom both end-of-treatment and sustained virologic response rate data were available as of September 2006. When both pegylated interferon alfa-2b and ribavirin were dosed by weight, the overall response rate was 11%, Dr. Marotta said. When stratified by genotype, however, rates were 16% in G1 patients, 7% in G2, and 7% in G3.

Further analysis is required to complete the program and to report rates of sustained virologic response in all enrolled patients. More accurate relapse rates will then be defined, Dr. Marotta concluded.

Dr. Marotta is a member of the Speakers' Bureau for Schering Plough; this study was supported by Schering Plough Canada.


[Presentation title: An Interim Analysis of the Canadian POWeR Program (Peginterferon Alfa-2b Prospective Optimal Weight-Based Dosing Response): Consistent SVR Rates Across All Weight Categories. Abstract 358]

E-Mail this DGDispatch to a colleague

To print, use this version