For adults with chronic hepatitis C, the fixed-dose combination of sofosbuvir (an NS5B RNA polymerase inhibitor) + velpatasvir (an NS5A protein inhibitor) + voxilaprevir (an NS3/4A protease inhibitor) (Vosevi° - Gilead Sciences) offers an advantage, particularly for certain patients after failure of combinations of other direct-acting antiviral drugs (1). In the European Union, this triple combination has been authorised for use in adolescents aged 12 years and older, weighing at least 30 kg (2). Evaluation is based on one non-comparative pharmacokinetic study including 21 adolescents aged 12 to 16 years who all received the combination of sofosbuvir + velpatasvir+voxilaprevir. Five patients had already received antiviral treatment for hepatitis C, but not a direct-acting antiviral. No patients had cirrhosis. All the adolescents had a sustained virological response 12 weeks after the end of antiviral treatment, and no virological failures were observed. In summary, in view of the small number of adolescents included and the scant data from this study, as well as the lack of evaluation in adolescents after failure of direct-acting antivirals, the efficacy of thistriple combination in adolescents is mainly based on extrapolation from the data available in adults. No previously unknown adverse effect was identified (2).
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