PEG-Intron/Ribavirin Pediatric Responder Studies Address Safety Concerns
Executive Summary
PEG-Intron/ribavirin combination studies in children with hepatitis C should consider enrolling only early responders to therapy to minimize adverse events, committee member Robert Fink, MD, Children's National Medical Center, suggested at an April 23 meeting of FDA's Anti-Infective Drugs Advisory Committee/Pediatric Subcommittee.