BACKGROUND/AIMS: Therapeutic options for hepatitis C non-responder patients are limited. METHODS: We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200 mg ribavirin. An 8-week induction-dosing regimen of 18 microg CIFN, followed by 9 microg for 40 weeks was compared to 9 microg CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1. RESULTS: Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology. CONCLUSIONS: Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required.
RCT Entities:
BACKGROUND/AIMS: Therapeutic options for hepatitis C non-responder patients are limited. METHODS: We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200 mg ribavirin. An 8-week induction-dosing regimen of 18 microg CIFN, followed by 9 microg for 40 weeks was compared to 9 microg CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1. RESULTS: Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology. CONCLUSIONS: Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required.
Authors: Alan D Tice; Michael Bannan; Kay Bauman; Tarquin Collis; Alba Hall; William Haning; Shoshana Hannemann; C Bradley Hare; Joseph Humphry; Robert Jao; Carroll Leevy; Heather Lusk; Edward Ochoa; Neal Palafox; Nancy Withers; Kenneth Akinaka Journal: Hawaii Med J Date: 2010-04
Authors: Morris Sherman; Stephen Shafran; Kelly Burak; Karen Doucette; Winnie Wong; Nigel Girgrah; Eric Yoshida; Eberhard Renner; Philip Wong; Marc Deschênes Journal: Can J Gastroenterol Date: 2007-06 Impact factor: 3.522