摘要
Background/Aims: Current therapies for patients with chronic hepatitis C viru s (HCV) do not achieve sustained viral clearance in most patients, and are assoc iated with severe toxic effects. Our aim was to investigate the efficacy and saf ety of etanercept as adjuvant to interferon and ribavirin in treatment- naive p atients with HCV. Methods: Double- blind, randomized, placebo controlled trial. Fifty patients with chronic HCV were randomly assigned to receive interferon al fa- 2b and ribavirin with either etanercept or placebo for 24 weeks. The main o utcome measure was the absence of HCV RNA at 24 weeks, the on treatment response at the end of the etanercept randomization period. Results: At 24 weeks, HCV RN A was absent in 63% (12/19) etanercept patients compared to 32% (8/25) place bo patients (P=0.04). In addition, patients receiving etanercept had lower frequ ency of most adverse events categories compared to placebo. Conclusions: Etanerc ept given for 24 weeks as adjuvant therapy to interferon and ribavirin significa ntly improved virologic response at the end of the etanercept randomization peri od among patients with HCV, and was associated with decreased incidence of most adverse effects associated with interferon and ribavirin.
Background/Aims: Current therapies for patients with chronic hepatitis C viru s (HCV) do not achieve sustained viral clearance in most patients, and are assoc iated with severe toxic effects. Our aim was to investigate the efficacy and saf ety of etanercept as adjuvant to interferon and ribavirin in treatment- naive p atients with HCV. Methods: Double- blind, randomized, placebo controlled trial. Fifty patients with chronic HCV were randomly assigned to receive interferon al fa- 2b and ribavirin with either etanercept or placebo for 24 weeks. The main o utcome measure was the absence of HCV RNA at 24 weeks, the on treatment response at the end of the etanercept randomization period. Results: At 24 weeks, HCV RN A was absent in 63% (12/19) etanercept patients compared to 32% (8/25) place bo patients (P=0.04). In addition, patients receiving etanercept had lower frequ ency of most adverse events categories compared to placebo. Conclusions: Etanerc ept given for 24 weeks as adjuvant therapy to interferon and ribavirin significa ntly improved virologic response at the end of the etanercept randomization peri od among patients with HCV, and was associated with decreased incidence of most adverse effects associated with interferon and ribavirin.
