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
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
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.
||Approximately 5000 patients were randomized in this trial.
||The present report concerns 65 Asian patients (genotype 1=37; genotypes
2/3=25) and 251 Hispanic patients (genotype 1=166; genotype 2/3=77) who
received at least 1 dose of ribavirin and were ? 65 kg.
||Of the 65 Asians, 34 (52.3%) achieved SVR vs 45.7% of Caucasians (P =
" SVR rate for Asians with genotype 1 was 15 of 37 (40.5%) vs 34.9% of
Caucasians (P = 0.48).
||SVR rate for Asians with genotype 2/ 3 was 18 of 25 (72%) vs 61.6% of
Caucasians (P = 0.29).
||SVR rate for Asians receiving ribavirin WBD was 21 of 32 (66%) vs 13 of
33 (39%) who received ribavirin FD (P = 0.04).
||Of the 251 Hispanic patients, 84 (33.5%) achieved SVR vs 45.7% of
Caucasians (P = 0.0002)
||Hispanics were 1.7 times less likely to achieve SVR than Caucasians.
||SVR rate for 159 Hispanics who finished a full course of treatment was
46.5% vs 55.3% for Caucasians (P = 0.0006).
||SVR for Hispanics with genotype 1 was 44 of 166 (24.1%) vs 34.9% for
Caucasians (P = 0.005).
||SVR for Hispanics with genotype 2/3 was 41 of 77 (53.6%) vs 61.6% for
Caucasians (P = 0.14).
||SVR for Hispanics receiving ribavirin WBD was 39 of 122 (32%) vs 45 of
129 (35%) receiving ribavirin FD (P = 0.6).
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