Abstract
Background: Available real-world data on the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) in pediatric patients are limited. In this prospective, open-label, single-center study, we aimed to present our real-life experience with a fixed dose of LDV/SOF (90/400 mg) for the treatment of chronic hepatitis C (CHC) genotypes 1 and 4 in children aged 12 to 17 years. Methods: We analyzed intention-to-treat (ITT) and per-protocol (PP) rates of sustained virological response (SVR), defined as undetectable HCV viral load at posttreatment week 12, in 37 participants treated with LDV/SOF according to the HCV genotype, baseline liver fibrosis, duration of treatment, and experience of the previous ineffective antiviral treatment. There were 32 patients infected with genotype 1 and 5 with genotype 4. Fourteen (38%) participants were treatment-experienced, two were coinfected with HIV, and three were cirrhotic. Two patients qualified for 24 weeks of therapy, and the remaining 35 received 12 weeks of LDV/SOF treatment. Results: The overall ITT SVR12 rate was 36/37 (97%). One patient was lost to follow-up after week 4 of therapy when his HCV RNA was undetectable. All 36 patients who completed the full protocol achieved SVR (36/36, 100%). PP analyses of SVR12 rates according to the HCV genotype, baseline liver fibrosis, duration of the treatment, and previous ineffective treatment were all 100%. A significant decrease in aminotransferase serum levels was observed in the subsequent weeks of the treatment and at SVR assessment compared to baseline. No serious adverse events were reported. Conclusions: The results of this study confirm previous observations of a suitable efficacy and safety profile of LDV/SOF for the treatment of CHC genotypes 1 and 4 in adolescents.
Highlights
It is estimated that over 3.25 million (95% confidence interval 2.07–3.90) children are infected with hepatitis C virus (HCV) globally, which corresponds to a prevalence of 0.13%(0.08–0.16) [1]
Baseline liver stiffness measurement (LSM) revealed significant fibrosis (F ≥ 2 points in METAVIR scale) in 4/37 (11%) patients, including 3/37 (8%) with compensated cirrhosis (Child–Pugh class A). Two of these cirrhotic patients were infected with genotype 1b HCV, and they had a history of previous ineffective treatment with interferon and ribavirin
Our study revealed a 100% efficacy and a suitable safety profile of LDV/SOF treatment in children aged 12 to 17 years infected with genotypes 1 and 4 HCV
Summary
It is estimated that over 3.25 million (95% confidence interval 2.07–3.90) children are infected with hepatitis C virus (HCV) globally, which corresponds to a prevalence of 0.13%(0.08–0.16) [1]. 3500 (2600–4200) subjects are considered to be living in Poland, which makes the HCV prevalence 0.05 (0.04–0.06) [1]. 2019, only 545 cases of hepatitis C were reported in patients aged 0–19 years, which suggests that most cases of HCV-infected children remain undiagnosed [2]. Younossi et al [6] showed that HCV infection in adolescents may be associated with decreased health-related quality of life, poor social functioning, and a reduction in intelligence and memory testing. To prevent these consequences of CHC, early anti-HCV treatment should be implemented. The first DAA, ledipasvir/sofosbuvir (LDV/SOF), was approved for use in children aged 12–17 years by the European Medical Agency (EMA), Amsterdam, The Netherlands, and U.S Food and
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