Jan 6, 2014 - according to MedDRA version 13.0. Results. A total of 581 (19%) patients experienced moderate, severe, or life-threatening infections as ...
MAJOR ARTICLE
Infections During Peginterferon/Ribavirin Therapy Are Associated With the Magnitude of Decline in Absolute Lymphocyte Count: Results of the IDEAL Study Michael T. Melia,1 Norbert Bräu,2 Fred Poordad,3 Eric J. Lawitz,3 Mitchell L. Shiffman,4 John G. McHutchison,5 Andrew J. Muir,6 Greg W. Galler,7 Lisa M. Nyberg,8 William M. Lee,9 Eugene Schiff,10 Jianmin Long,11 Stephanie Noviello,11,a Clifford A. Brass,11,b Lisa D. Pedicone,11,c and Mark S. Sulkowski1 1
Johns Hopkins University School of Medicine, Baltimore, Maryland; 2Bronx Veterans Affairs Medical Center, New York; 3University of Texas Health Science Center, San Antonio; 4Liver Institute of Virginia, Bon Secours Health System, Richmond; 5Gilead, Foster City, California; 6Duke University Medical Center, Durham, North Carolina; 7Kelsey Research Foundation, Houston, Texas; 8Kaiser Permanente, San Diego Medical Center, California; 9University of Texas Southwestern Medical Center, Clinical Center for Liver Diseases, Dallas; 10University of Miami Center for Liver Diseases, Florida; and 11Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey
Background. Myelosuppression due to pegylated interferon (peg-IFN) is common during treatment for hepatitis C virus. The relationship between infection risk and decreases in leukocyte lines, however, is not well established. The objective of this analysis was to determine the incidence of and risk factors for infections during peg-IFN/ribavirin (RBV) therapy. Methods. A total of 3070 treatment-naive, chronic hepatitis C genotype 1–infected patients were treated for up to 48 weeks with peg-IFN alfa-2b 1.5 µg/kg/week or 1 µg/kg/week, or peg-IFN alfa-2a 180 µg/week plus RBV. Ontreatment leukocyte counts were obtained every 2–6 weeks. Dose reduction was required for a neutrophil count
