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A fixed-dose combination of sofosbuvir and ledipasvir, two direct-acting antivirals (DAAs) used for the treatment of chronic hepatitis C virus (HCV) infection. Sofosbuvir is a nucleotide analog that acts as an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, while ledipasvir is an inhibitor of the HCV NS5A protein. This combination is particularly significant in Egypt for treating genotype 4 HCV, the most prevalent strain in the region. The National Liver Institute in Egypt has conducted specific clinical trials evaluating a half-dose generic formulation (Heterosofir) for safety and efficacy in pediatric populations aged 3 to 12 years, demonstrating high sustained virological response (SVR) rates.
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