Efficacy of Sofosbuvir/Ledipasvir in Adolescents With Chroni
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Sofosbuvir/Ledipasvir (SOF/LDV) has been approved by the European Medicine Agency (EMA) for the treatment of children and adolescents (at least 3 years of age) with chronic hepatitis C (CHC) genotype 1, 3, and 4 infection. The aim of this study was to evaluate the efficacy and safety of SOF/LDV in adolescents (12 to less than 18 years old) with CHC in the real-world setting.

Patients received the fixed-dose combination of SOF/LDV (400/90 mg) once daily ± ribavirin as per EMA approval and recommendations. The key efficacy endpoint was sustained virological response 12 weeks after the end of treatment (SVR12) as per intention-to-treat analysis. Safety was assessed by adverse events and clinical/laboratory data.

Results:
78 consecutive adolescents were enrolled and treated between June 2018 and December 2019.
-Genotype distribution was as follows:
genotype 1 (82.1%), 3 (2.5%), and 4 (15.4%).
-76 patients completed treatment and follow-up. Overall, SVR12 was 98.7%.
-One patient was lost to follow-up after 4 weeks of treatment; 1 patient completed treatment and missed the follow-up visit. No virological breakthrough or relapse were observed. No patient experienced grade 3 to 4 adverse event or serious adverse event.

In particular, the results of this real-world study confirmed the high efficacy and the optimal safety profile of SOF/LDV for treatment of CHC in adolescents.

Source: https://journals.lww.com/jpgn/Abstract/2021/01000/Efficacy_of_Sofosbuvir_Ledipasvir_in_Adolescents.21.aspx
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