BACKGROUND/AIMS: The majority of patients with genotype 1 do not respond to interferon (IFN) plus ribavirin. Limited data exist on the use of induction followed by combination therapy. METHODS: In this prospective study of 28 patients infected with genotype 1, randomization involved eitherdaily or twice daily high dose IFN for 6 weeks, followed by standard therapy of 3 million units three times a week in combination with ribavirin for an additional 42 weeks. Hepatitis C virus (HCV) RNA was quantitated before and frequently during treatment. RESULTS: The best correlate of response was delta (the infected cell loss rate). Sixteen patients continued on the study because they had at least a 2 log drop in their HCV RNA levels by week 12; all but one were PCR negative for HCV RNA at 48 weeks, and 14 of these 16 patients continued to be PCR negative at 72 weeks. Both African-Americans in our trial failed to respond to therapy, and differences were evident during the induction phase. CONCLUSIONS: This randomized study of induction IFN therapy followed by combination IFN plus ribavirin yielded the highest rate of sustained response (50%) reported to date in chronically HCV-infected patients with genotype 1. The predictive value of the infected cell loss rate needs to be evaluated prospectively in larger studies, particularly in patients receiving pegylated IFN.
RCT Entities:
BACKGROUND/AIMS: The majority of patients with genotype 1 do not respond to interferon (IFN) plus ribavirin. Limited data exist on the use of induction followed by combination therapy. METHODS: In this prospective study of 28 patients infected with genotype 1, randomization involved either daily or twice daily high dose IFN for 6 weeks, followed by standard therapy of 3 million units three times a week in combination with ribavirin for an additional 42 weeks. Hepatitis C virus (HCV) RNA was quantitated before and frequently during treatment. RESULTS: The best correlate of response was delta (the infected cell loss rate). Sixteen patients continued on the study because they had at least a 2 log drop in their HCV RNA levels by week 12; all but one were PCR negative for HCV RNA at 48 weeks, and 14 of these 16 patients continued to be PCR negative at 72 weeks. Both African-Americans in our trial failed to respond to therapy, and differences were evident during the induction phase. CONCLUSIONS: This randomized study of induction IFN therapy followed by combination IFN plus ribavirin yielded the highest rate of sustained response (50%) reported to date in chronically HCV-infectedpatients with genotype 1. The predictive value of the infected cell loss rate needs to be evaluated prospectively in larger studies, particularly in patients receiving pegylated IFN.
Authors: John Scott; Sarah Holte; Thomas Urban; Caitlin Burgess; Erica Coppel; Chia Wang; Larry Corey; John McHutchison; David Goldstein Journal: J Infect Dis Date: 2011-08-01 Impact factor: 5.226
Authors: Christian G Schüttler; Christine Thomas; Thomas Discher; Georg Friese; Jürgen Lohmeyer; Ralph Schuster; Stephan Schaefer; Wolfram H Gerlich Journal: J Clin Microbiol Date: 2004-05 Impact factor: 5.948
Authors: Vincent C Emery; Oriol Manuel; Anders Asberg; Xiaoli Pang; Deepali Kumar; Anders Hartmann; Jutta K Preiksaitis; Mark D Pescovitz; Halvor Rollag; Alan G Jardine; Christoph G Gahlemann; Atul Humar Journal: J Clin Virol Date: 2012-03-10 Impact factor: 3.168