The European Medicines Agency (EMA) has authorised Sofosbuvir/Ledipasvir (SOF/LDV) for the treatment of children and adolescents with chronic hepatitis C (CHC) genotypes 1, 3, and 4. The purpose of this study was to assess the effectiveness and safety of SOF/LDV in adolescents with CHC. A multicenter, prospective, open-label research comprising 12 Italian centres. According to EMA approval and guidelines, patients were given a fixed-dose combination of SOF/LDV (400/90 mg) once daily ribavirin. According to the intention-to-treat analysis, the main effectiveness objective was sustained virological response 12 weeks after the conclusion of therapy (SVR12). Adverse occurrences and clinical/laboratory data were used to assess safety. Between June 2018 and December 2019, 78 teenagers were enrolled and treated in a row. The genotype distribution was as follows: 1, 3, and 4. Seventy-six patients finished therapy and were followed up on. SVR12 was 98.7 percent in total. After 4 weeks of treatment, one patient was lost to follow-up; another finished treatment but skipped the follow-up session. There was no virological breakthrough or relapse. No patient had an adverse event of grade 3 to 4 or a major adverse event.
The findings of this real-world trial validated SOF/great LDV’s effectiveness and optimal safety profile for the treatment of CHC in adolescents.
