M Simin1, J Brok, D Stimac, C Gluud, L L Gluud. 1. The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. marija.simin@gmail.com
Abstract
BACKGROUND: About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy. AIM: To evaluate the beneficial and harmful effects of pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection. METHODS: We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, Science Citation Index Expanded and contacted pharmaceutical companies and authors of trials (to March 2005). RESULTS: We included 18 randomized clinical trials with 4811 patients. Eleven trials (61%) had allocation bias risks and all had assessment bias risk because of lack of blinding. Compared with interferon plus ribavirin, pegylated interferon plus ribavirin had significant beneficial effects on sustained virological response [risk ratio (RR): 0.80; 95% CI: 0.74-0.88]. Data were insufficient to determine impact on long-term outcomes. Pegylated interferon plus ribavirin significantly increased dose reductions (RR: 1.44; 95% CI: 1.14-1.82) and adverse events including neutropenia (RR: 2.25; 95% CI: 1.58-3.21), thrombocytopenia (RR: 2.28; 95% CI: 1.14-4.54), arthralgia (RR: 1.19; 95% CI: 1.05-1.35), and injection-site reaction (RR: 2.56; 95% CI: 1.06-6.22). CONCLUSIONS: Pegylated interferon plus ribavirin compared with interferon plus ribavirin increased the proportion of patients with sustained virological response, but at the cost of more adverse events.
BACKGROUND: About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy. AIM: To evaluate the beneficial and harmful effects of pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection. METHODS: We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, Science Citation Index Expanded and contacted pharmaceutical companies and authors of trials (to March 2005). RESULTS: We included 18 randomized clinical trials with 4811 patients. Eleven trials (61%) had allocation bias risks and all had assessment bias risk because of lack of blinding. Compared with interferon plus ribavirin, pegylated interferon plus ribavirin had significant beneficial effects on sustained virological response [risk ratio (RR): 0.80; 95% CI: 0.74-0.88]. Data were insufficient to determine impact on long-term outcomes. Pegylated interferon plus ribavirin significantly increased dose reductions (RR: 1.44; 95% CI: 1.14-1.82) and adverse events including neutropenia (RR: 2.25; 95% CI: 1.58-3.21), thrombocytopenia (RR: 2.28; 95% CI: 1.14-4.54), arthralgia (RR: 1.19; 95% CI: 1.05-1.35), and injection-site reaction (RR: 2.56; 95% CI: 1.06-6.22). CONCLUSIONS: Pegylated interferon plus ribavirin compared with interferon plus ribavirin increased the proportion of patients with sustained virological response, but at the cost of more adverse events.
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Authors: Hamad Al Ashgar; Ahmed Helmy; Mohamed Q Khan; Khalid Al Kahtani; Mohammed Al Quaiz; Mohammed Rezeig; Ingvar Kagevi; Abdullah Alshehri; Abdullah Al Kalbani; Khalid Al Swat; Salim Dahab; Naser Elkum; Mohammed Al Fadda Journal: Ann Saudi Med Date: 2009 Jan-Feb Impact factor: 1.526