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In the context of its use with interferon-based regimens for treating hepatitis C virus (HCV) infection, ribavirin has been associated with adverse events (AEs) such as hemolytic anemia, fatigue, pruritus, and rash. However, little is known about the safety and tolerability of ribavirin when used with interferon-free regimens.
To investigate this issue, researchers conducted a secondary analysis of safety data from three phase III trials in which 1080 patients with HCV genotype 1 infection received a fixed-dose combination tablet of ledipasvir/sofosbuvir (90 mg/400 mg) daily and 872 received ledipasvir/sofosbuvir plus ribavirin (1000–1200 mg) daily for 8, 12, or 24 weeks.
Treatment-related AEs occurred in 71% of patients receiving ribavirin c…