Gastroenterology

Gastroenterology

Volume 131, Issue 2, August 2006, Pages 470-477
Gastroenterology

Clinical–liver, pancreas, and biliary tract
Peginterferon and Ribavirin Treatment in African American and Caucasian American Patients With Hepatitis C Genotype 1

https://doi.org/10.1053/j.gastro.2006.06.008Get rights and content

Background & Aims: Compared with Caucasian Americans (CA), African Americans (AA) with chronic hepatitis C are less likely to respond to interferon-based antiviral therapy. Methods: In a multicenter treatment trial, 196 AA and 205 CA treatment-naive patients with hepatitis C virus (HCV) genotype 1 infection were treated with peginterferon alfa-2a (180 μg/wk) and ribavirin (1000–1200 mg/day) for up to 48 weeks. The primary end point was sustained virologic response (SVR). Results: Baseline features were similar among AA and CA, including HCV-RNA levels and histologic severity, but AA had higher body weights, a higher prevalence of diabetes and hypertension, and lower alanine transaminase levels (P < .001 for all). The SVR rate was 28% in AA and 52% in CA (P < .0001). Racial differences in viral responses were evident as early as treatment week 4. Breakthrough viremia was more frequent among AA than CA (13% vs 6%, P = .05); relapse rates were comparable (32% vs 25%, P = .30). Proportions of patients with serious adverse events and dose modifications and discontinuations were similar among AA and CA. In multiple regression analyses, CA had a higher SVR rate than AA (relative risk, 1.96; 95% confidence interval, 1.48–2.60; P < .0001). Other factors independently associated with higher SVR included female sex, lower baseline HCV-RNA level, less hepatic fibrosis, and more peginterferon taken. Conclusions: AA with chronic hepatitis C genotype 1 have lower rates of virologic response to peginterferon and ribavirin than CA. These differences are not explained by disease characteristics, baseline viral levels, or amount of medication taken.

Section snippets

Patient Sample

Adult patients between the ages of 18 and 70 years with chronic HCV genotype 1 infection who had not been treated previously were eligible for enrollment. Patients were required to have HCV RNA in serum, compensated liver disease, and histologic evidence of chronic hepatitis C on liver biopsy examination performed within the previous 18 months. An increased serum alanine transaminase level was not required. Only patients who designated themselves as “African American/black” or “Caucasian/white”

Baseline Features

Of 535 patients screened, 401 met the entry criteria and were enrolled. The 2 groups that consisted of 196 AA and 205 CA did not differ significantly in regards to sex, age, estimated duration of infection, suspected source of infection, or alcohol use (Table 1). Education greater than high school level was less common among AA. AA patients were heavier and were more likely to have a history of diabetes and hypertension compared with CA. AA had lower serum ALT values than CA but similar liver

Discussion

In this study, response rates to the current, optimal regimen of antiviral therapy of hepatitis C were significantly lower among AA compared with CA patients (28% vs 52%). This difference was not explained by factors known to be associated with poor response such as baseline HCV-RNA levels, sex, age, weight, degree of fibrosis, or amount of drug taken, even though AA and CA patients differed in the frequency of several of these predictive factors (body weight, amount of drug taken). Factors

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    The prevalence of extranodal and bulky disease in the HIV/HCV-coinfected group was also comparable to patients with HIV-associated lymphoma.35 Many studies have established that black patients have lower virologic response rates to IFN alone or IFN plus ribavirin than do white patients.36,37 With the advent of sofosbuvir-based DAAs, SVR rates have improved remarkably in this population.

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This study was funded as a cooperative agreement by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with co-support from the National Center on Minority Health and Health Disparities (NCMHD) and the Intramural Research Program of the National Cancer Institute (NCI) with further support under a Cooperative Research and Development Agreement (CRADA) with Roche Laboratories, Inc. Grant numbers: U01 DK60329, U01 DK60340, U01 DK60324, U01 DK60344, U01 DK60327, U01 DK60335, U01 DK60352, U01 DK60342, U01 DK60345, U01 DK60309, U01 DK60346, U01 DK60349, U01 DK60341. Other support: National Center for Research Resources (NCRR) General Clinical Research Centers Program grants: M01 RR00645 (New York Presbyterian), M02 RR000079 (University of California, San Francisco), M01 RR16500 (University of Maryland), M01 RR000042 (University of Michigan), M01 RR00046 (University of North Carolina).

Members of Virahep-C contributing to the study include: from the Beth Israel Deaconess Medical Center, Boston, MA: Nezam Afdhal, MD (Principal Investigator), Tiffany Geahigan, PA-C, MS (Research Coordinator); from the New York-Presbyterian Medical Center, New York, NY: Robert S. Brown, Jr., MD, MPH (Principal Investigator), Lorna Dove, MD, MPH (Co-Investigator), Shana Stovel, MPH (Study Coordinator), Maria Martin (Study Coordinator); from the University of California, San Francisco, San Francisco, CA: Norah Terrault, MD, MPH (Principal Investigator), Stephanie Straley, PA-C, Eliana Agudelo, PA-C, Melissa Hinds, BA (Clinical Research Coordinator), Jake Heberlein (Clinical Research Coordinator); from Rush University, Chicago, IL: Thelma E. Wiley, MD (Principal Investigator), Monique Williams, RN (Study Coordinator); from the University of Maryland, Baltimore, MD: Charles D. Howell, MD (Principal Investigator), Kelly Gibson (Project Coordinator), Karen Callison, RN (Study Coordinator), Jane Lewis, RN (Study Coordinator); from the University of Miami, Miami, FL: Lennox J. Jeffers, MD (Principal Investigator), Shvawn McPherson Baker, PharmD (Co-Investigator), Maria DeMedina, MSPH (Project Manager), Carol Hermitt, MD (Project Coordinator); from the University of Michigan, Ann Arbor, MI: Hari S. Conjeevaram, MD, MS (Principal Investigator), Robert J. Fontana, MD (Co-Investigator), Donna Harsh, MS (Study Coordinator); from the University of North Carolina, Chapel Hill, NC: Michael W. Fried, MD (Principal Investigator [K24 DK066144]), Scott R. Smith, PhD (Co-Investigator), Dickens Theodore, MD, MPH (Co-Investigator), Steven Zacks, MD, MPH, FRCPC (Co-Investigator [K23 DK064762]), Roshan Shrestha, MD (Co-Investigator), Karen Dougherty, NP (Co-Investigator), Paris Davis (Study Coordinator), Shirley Brown (Study Coordinator); from St. Louis University, St. Louis, MO: John E. Tavis, PhD (Principal Investigator), Adrian Di Bisceglie, MD (Co-Investigator), Ermei Yao, PhD (Co-Investigator), Maureen Donlin, PhD (Co-Investigator), Nathan Cannon, BS (Graduate Student), Ping Wang, BS (Lab Technician); from Cedars-Sinai Medical Center, Los Angeles, CA: Huiying Yang, MD, PhD (Principal Investigator), George Tang, PhD (Project Scientist), Dai Wang, PhD (Project Scientist); from the University of Colorado Health Sciences Center, Denver, CO: Hugo R. Rosen, MD (Principal Investigator), James R. Burton, MD (Co-Investigator), Jared Klarquist (Lab Technician); from Veteran’s Administration, Portland, OR: Scott Weston (Lab Technician); from Indiana University, Bloomington, IN: Milton W. Taylor, PhD (Principal Investigator), Corneliu Sanda, MD (post-doctoral associate), Takuma Tsukahara, MS (statistician), Mary Ferris (lab assistant); from the Data Coordinating Center, Graduate School of Public Health at the University of Pittsburgh, Pittsburgh, PA: Steven H. Belle, PhD (Principal Investigator), Richard A. Bilonick, PhD (Statistician), Geoffrey Block, MD (Co-Investigator), Jennifer Cline, BS (Data Manager), Marika Haritos, MS (Statistician), KyungAh Im, MS (Statistician), Stephanie Kelley, MS (Data Manager), Sherry Kelsey, PhD (Co-Investigator), Laurie Koozer, BA (Project Coordinator), Sharon Lawlor, MBA (Data Coordinator), Stephen B. Thomas, PhD (Co-Investigator), Abdus Wahed, PhD (Statistician), Yuling Wei, MS (Project Coordinator), Leland J. Yee, PhD (Consultant), Song Zhang, MS, MD (Statistician); from the National Institute of Diabetes and Digestive and Kidney Diseases: Patricia Robuck, PhD, MPH (Project Scientist), James Everhart, MD, MPH (Scientific Advisor), Jay H. Hoofnagle, MD (Scientific Advisor), Edward Doo, MD (Scientific Advisor), T. Jake Liang, MD (Scientific Advisor), Leonard B. Seeff, MD (Scientific Advisor); from the National Cancer Institute: David E. Kleiner, MD, PhD (Central Pathologist).

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