Sustained Virological Response to PegIntron Plus Ribavirin in Asian and Hispanic Patients
Retrospective examination of available data strongly suggests that Asian patients experience a higher rate of sustained virological response (SVR) to interferon plus ribavirin therapy for chronic hepatitis C compared with Caucasian patients, while Hispanic patients have a lower SVR than Caucasians. It is well established that African-American patients have poorer response than other racial/ethnic groups.
In the current study, presented at the 57th AASLD annual meeting taking place this week in Boston, researchers at 17 U.S. medical centers* evaluated SVR rates in Asian and Hispanic patients with chronic hepatitis C enrolled in the WIN-R trial, a large U.S. multicenter study comparing fixed dose (FD) vs weight based dosing (WBD) of ribavirin combined with pegylated interferon alfa-2b (PegIntron).
Patients were randomized to receive PegIntron 1.5 mcg/kg once weekly combined with ribavirin 800 mg (FD) or 800-1400 mg/day (WBD). Treatment was for 48 weeks, with 24 weeks follow-up.
The SVR rate was based on intent-to-treat (ITT) analysis and defined as undetectable HCV RNA by central quantitative TaqMan assay (lower limit of detection < 29 IU/mL or 100 copies/mL) 24 weeks after the completion of treatment.
Dose reductions of ribavirin were required for hemoglobin (Hgb) levels < 10 g/dL and discontinuation for Hgb < 8.5. Erythropoietin (EPO) was permitted concomitant with ribavirin dose reduction for Hgb < 10.
Based on these findings, the authors concluded, "Compared to Caucasian patients, [PegIntron] 1.5 mcg/kg results in a significantly lower SVR for Hispanic patients by ITT analysis and for those who completed therapy."
They added that, "SVR for Asian patients vs Caucasian patients trended higher, but was not statistically significant."
This study was supported by Schering-Plough Corp.
*Baptist Medical Center, Kansas City, MO; University of California Irvine, Orange, CA; Weill Cornell Medical College, New York, NY; Columbia Presbyterian Medical Center, New York, NY; Beth Israel Deaconess Medical Center, Boston, MA; Indiana University School of Medicine, Indianapolis, IN, USA; Atlantic Gastroenterology Associates, PA, Egg Harbor Township, NJ; Austin Gastroenterology, Austin, TX; East Bay Liver Clinic, San Francisco, CA; Indianapolis Gastrointestinal Research Foundation, Indianapolis, IN; Bach and Godofsky, MD PA, Bradenton, FL; Northwest Georgia Gastroenterology Associates, PC, Marietta, GA; North Shore Long Island Jewish Health System, Manhasset, NY; Northwestern University, Chicago, IL; Gastroenterology Consultants, PA, Houston, TX; Albert Einstein Medical Center, Philadelphia, PA; Schering-Plough Research Institute, Kenilworth, NJ;
B Freilich, K Hu, I Jacobson, and others. Prospective Analysis of Sustained Virologic Response (SVR) to Peg-interferon (PEG IFN) Alfa-2b and Ribavirin Treatment in Asian and Hispanic Patients with Chronic Hepatitis C: Results from the WIN-R Trial. 57th AASLD. October 27-31, 2006. Boston, MA. Abstract 349.