caa a22 4500 445795182 CHVBK 20180317145122.0 cr unu---uuuuu 170323e20110301xx s 000 0 eng 10.1007/s10620-010-1504-y doi (NATIONALLICENCE)springer-10.1007/s10620-010-1504-y U.S. Multicenter Pilot Study of Daily Consensus Interferon (CIFN) Plus Ribavirin for "Difficult-to-Treat” HCV Genotype 1 Patients [Elektronische Daten] [Samuel Ho, Bashar Aqel, Eric Dieperink, Shanglei Liu, Lori Tetrick, Yngve Falck-Ytter, Charles DeComarmond, Coleman Smith, Daniel McKee, William Boyd, Clark Kulig, Edmund Bini, Marcos Pedrosa] Background: Patients with chronic hepatitis C genotype 1 (HCV-1) and difficult-to-treat characteristics respond poorly to pegylated interferon alfa and ribavirin (RBV), and could benefit from an interferon with increased activity (consensus interferon or CIFN), favorable viral kinetics from daily dosing, and a longer duration of therapy. The purpose of this pilot study was to determine the efficacy and safety of daily CIFN+RBV for initial treatment of patients with HCV-1 infection. Methods: Patients with difficult-to-treat characteristics (92% male, 33% African American, 78% Veterans Affairs [VA]; 67% high viral load, 59% stage 3-4 fibrosis, and mean weight of 204lbs) were enrolled at seven VA and two community medical centers. They were randomized to daily CIFN (15mcg/day SQ) and RBV (1-1.2g/d PO) given for either 52weeks (group A, n=33) or 52-72weeks (from time of viral response +48weeks) (group B, n=31). Results: Intention to treat analysis for treatment groups A and B demonstrated 33% (11/33) and 32% (10/31) sustained virologic response (SVR), respectively. Only 2/31 patients in group B received more than 52weeks of treatment. The overall group demonstrated a 31% (20/64) rapid virologic response rate (RVR), 54% (34/64) end of treatment virologic response and a 33% (21/64) SVR. Patients with RVR at 4weeks, early virologic response from 8-12weeks, and late virologic response from 16-24weeks demonstrated SVR of 75% (15/20), 31% (4/13), and 22% (2/9), respectively. Overall early non-protocol discontinuation occurred in 26/64 (40%) patients. Conclusion: Daily CIFN and ribavirin for initial treatment of HCV-1 patients has potential for achieving a relatively high RVR rate, but discontinuations are frequent and successful use of this regimen is highly dependent on adequate patient support to maintain adherence. The Author(s), 2011 Consensus interferon nationallicence Hepatitis C nationallicence Ribavirin nationallicence Veterans Affairs nationallicence Ho Samuel VA San Diego Healthcare System, 3350 La Jolla Village Drive, 92161, San Diego, CA, USA aut Aqel Bashar Department of Medicine, Minneapolis VA Medical Center, Minneapolis, MN, USA aut Dieperink Eric Departments of Psychiatry and Research, Minneapolis VA Medical Center, Minneapolis, MN, USA aut Liu Shanglei VA San Diego Healthcare System, 3350 La Jolla Village Drive, 92161, San Diego, CA, USA aut Tetrick Lori Departments of Psychiatry and Research, Minneapolis VA Medical Center, Minneapolis, MN, USA aut Falck-Ytter Yngve Louis Stokes Cleveland VA Medical Center, Cleveland, OH, USA aut DeComarmond Charles W. G. Hefner VA Medical Center, Salisbury, NC, USA aut Smith Coleman Minnesota Gastroenterology, Minneapolis, MN, USA aut McKee Daniel Northland Gastroenterology, Duluth, MN, USA aut Boyd William James A. Haley Veterans' Hospital, Tampa, FL, USA aut Kulig Clark VA Eastern Colorado Healthcare System, Denver, CO, USA aut Bini Edmund VA New York Harbor Healthcare System, New York, NY, USA aut Pedrosa Marcos VA Boston Healthcare System, Boston, MA, USA aut Digestive Diseases and Sciences Springer US; http://www.springer-ny.com 56/3(2011-03-01), 880-888 0163-2116 56:3<880 2011 56 10620 https://doi.org/10.1007/s10620-010-1504-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10620-010-1504-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Ho Samuel VA San Diego Healthcare System, 3350 La Jolla Village Drive, 92161, San Diego, CA, USA aut NATIONALLICENCE 700 1- Aqel Bashar Department of Medicine, Minneapolis VA Medical Center, Minneapolis, MN, USA aut NATIONALLICENCE 700 1- Dieperink Eric Departments of Psychiatry and Research, Minneapolis VA Medical Center, Minneapolis, MN, USA aut NATIONALLICENCE 700 1- Liu Shanglei VA San Diego Healthcare System, 3350 La Jolla Village Drive, 92161, San Diego, CA, USA aut NATIONALLICENCE 700 1- Tetrick Lori Departments of Psychiatry and Research, Minneapolis VA Medical Center, Minneapolis, MN, USA aut NATIONALLICENCE 700 1- Falck-Ytter Yngve Louis Stokes Cleveland VA Medical Center, Cleveland, OH, USA aut NATIONALLICENCE 700 1- DeComarmond Charles W. G. Hefner VA Medical Center, Salisbury, NC, USA aut NATIONALLICENCE 700 1- Smith Coleman Minnesota Gastroenterology, Minneapolis, MN, USA aut NATIONALLICENCE 700 1- McKee Daniel Northland Gastroenterology, Duluth, MN, USA aut NATIONALLICENCE 700 1- Boyd William James A. Haley Veterans' Hospital, Tampa, FL, USA aut NATIONALLICENCE 700 1- Kulig Clark VA Eastern Colorado Healthcare System, Denver, CO, USA aut NATIONALLICENCE 700 1- Bini Edmund VA New York Harbor Healthcare System, New York, NY, USA aut NATIONALLICENCE 700 1- Pedrosa Marcos VA Boston Healthcare System, Boston, MA, USA aut NATIONALLICENCE 773 0- Digestive Diseases and Sciences Springer US; http://www.springer-ny.com 56/3(2011-03-01), 880-888 0163-2116 56:3<880 2011 56 10620 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer