Abstract
Background: There are limited data available on the influence of direct-acting antivirals used to treat chronic hepatitis C (CHC) on growth in children. In this study, we aimed to analyze the growth parameters in children treated with ledipasvir/sofosbuvir (LDV/SOF). Methods: We included 38 patients (16 girls and 22 boys) aged 10–17 years treated with LDV/SOF for CHC (33 infected with genotype 1 and 5 with genotype 4; 36 were treated for 12 weeks, and 2 for 24 weeks according to the current guidelines). Patient weight and height were measured at baseline, after 4 weeks of treatment, at the end of the treatment (EOT), and 12 weeks and one year after the EOT. Body mass index (BMI), BMI z and height-for-age (HA) z scores were calculated according to the WHO Child Growth Standards and Growth reference data using the WHO anthropometric calculator AnthroPlus v. 1.0.4. In addition, correlations between BMI z scores and liver fibrosis (liver stiffness measurement, LSM), the aspartate transaminase (AST)-to-platelet ratio index (APRI), fibrosis-4 index (FIB-4) and liver steatosis (controlled attenuation parameter, CAP) were analyzed. Results: At baseline, 5/38 (13%) patients were obese (BMI z score > 2 SD), 4/38 (11%) were overweight, and 29 (76%) were normal. A significant increase was observed in mean weight, height and BMI both 12 weeks and one year after the treatment compared to the baseline, whereas no differences were observed for BMI z scores and HA z scores. Baseline BMI z scores correlated with alanine aminotransferase levels (r = 0.33, 95% CI 0.01–0.58, p = 0.04), LSM (r = 0.40, 95% CI 0.09–0.65, p = 0.01), the APRI (r = 0.33, 95% CI 0.02–0.59, p = 0.03), and the CAP (r = 0.40, 95% CI 0.08–0.64, p = 0.01). No similar correlations were reported at 12 weeks posttreatment. Conclusions: Treatment with LDV/SOF in children with CHC (genotypes 1 and 4) did not negatively influence the patients’ growth. However, higher baseline BMI z scores correlated with more advanced liver fibrosis and steatosis in children with CHC.
Highlights
Background iationsTherapies based on direct acting antivirals (DAAs) are currently considered a standard of care in patients with chronic hepatitis C (CHC)
Significant increase was observed in mean weight, height and Body mass index (BMI) both 12 weeks and one year after the treatment compared to the baseline, whereas no differences were observed for BMI z scores and HA z scores
Higher baseline BMI z scores correlated with more advanced liver fibrosis and steatosis in children with CHC
Summary
Therapies based on direct acting antivirals (DAAs) are currently considered a standard of care in patients with chronic hepatitis C (CHC). In 2017, the first DAA, ledipasvir/sofosbuvir (LDV/SOF), was approved for pediatric patients infected with hepatitis. Interferon (IFN)-based therapies, which were considered a standard of care for CHC before the era of DAAs, had a significant impact on the growth parameters in pediatric patients [7]. Treatment with pegylated IFN was associated with significant changes in body weight, growth, and body mass index (BMI) in children [7]. These effects were generally reversible; high-for-age z scores (HA z scores) did not return to baseline after two years of observation, which indicates the Licensee MDPI, Basel, Switzerland
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