HCV Polymerase Inhibitor R7128 Demonstrates Good Antiviral Activity in Genotype 2 or 3 Prior Non-responders and Relapsers
Given the suboptimal efficacy, side effects, and cost of interferon-based
therapy for chronic hepatitis C virus (HCV) infection, investigators have
explored several novel drugs that directly target various stages of the
viral lifecycle -- an approach called "STAT-C."
• At week 4, 90% of patients receiving R7128 achieved RVR (HCV RNA < 15 IU/mL), compared with 60% of those receiving placebo.Based on these preliminary results, the investigators suggested that "R7128 1500 mg [twice-daily] combined with [pegylated interferon/ribavirin] in prior HCV genotype 2/3 non-responders provides a high rate of RVR (> 86%), similar to R7128 + [standard of care] in genotype 1 non-responders, with an acceptable side-effect profile."
"These high response rates in a difficult-to-treat patient population suggest that combination therapy featuring R7128 deserves further exploration in both treatment-naive and non-responsive genotype 2/3 patients with HCV," they concluded.
Race/ethnicity and Weight
In a related study, investigators performed a sub-analysis of 2 cohorts (n = 25 each) of genotype 1 patients in the same study, looking at differences in response according to race/ethnicity and weight. Cohort 1 received 500 mg twice-daily R7128 or placebo while Cohort 2 received 1500 mg twice-daily R7128 or placebo, all with plus pegylated interferon/ribavirin.
Among the 50 subjects randomized into these 2 cohorts, 48% were white, 24% were Latino, 16% were African-American, and 8% were classified as "other." 54% of whites, 33% of Latinos, 38% of African-Americans, and 75% of "other" patients weighed > 85 kg. Proportions with body mass index (BMI) > 30 were 15%, 42%, 25%, and 25%, respectively.
• Among participants receiving placebo + standard of care, only 1 white patient (10%) achieved RVR.Based on these findings, the investigators concluded, "R7128 administered in combination with [pegylated interferon + ribavirin] for 28 days demonstrated clinically significant antiviral potency regardless of race/ethnicity, with a numerical improvement in RVR rates in Latino patients who received R7128 1500 mg [twice-daily]."
Auckland Clinical Studies Limited, Auckland, New Zealand; Fundacion de Investigacion d Diego, Santurce, Puerto Rico; University of Florida, Gainesville, FL; Weill Cornell Medical College, New York, NY; Duke Clinical Research Institute, Durham, NC; University of Miami, Miami, FL; Quest Clinical Research, San Francisco, CA; Orlando Immunology Center, Orlando, FL; University of Colorado, , Aurora, CO; University of Pennsylvania, Philadelphia, PA; Pharmasset, Inc., Princeton, NJ; Roche, Palo Alto, CA.
EJ Gane, M Rodriguez-Torres, DR Nelson, and others. Antiviral Activity of the HCV Nucleoside Polymerase Inhibitor R7128 In HCV Genotype 2 and 3 Prior Non-Responders: Interim Results of R7128 1500mg BID with PEG-IFN and Ribavirin For 28 Days. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract LB10.
M Rodriguez-Torres; J Lalezari, EJ Gane, and others. Potent Antiviral Response to the HCV Nucleoside Polymerase Inhibitor R7128 for 28 Days With Peg-IFN and Ribavirin: Subanalysis by Race/Ethnicity, Weight and HCV Genotype. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 1899.
|Print this page Previous Page|
What is hepatitis? |
Our Mission |
Who's Involved |
Hepatitis C News |
Upcoming Events |
Gift Cards |
HCV Awareness Items | Related Links | From the CEO | To Whom It May Concern |
Bulletins | Message Board | Webrings & Awards | Contact Information
|Copyright © Hepatitis C Association Inc. All rights reserved.|