The Influence of Treatment With Sofosbuvir/Velpatasvir on Children's Growth-Results of the PANDAA-PED Study

Pediatr Infect Dis J. 2025 Jan 1;44(1):1-5. doi: 10.1097/INF.0000000000004504. Epub 2024 Sep 4.

Abstract

Background: The aim of this study was to evaluate the influence of treatment of hepatitis C with sofosbuvir and velpatasvir (SOF/VEL) on children's growth.

Methods: Fifty children 6-18 years of age were successfully treated for hepatitis C with a 12-week course of SOF/VEL fixed dose adjusted to the body weight in the PANDAA-PED (Treatment of chronic hepatitis C in children 6-18 years of age using a pangenotypic direct-acting antiviral sofosbuvir/velpatasvir) project. Growth parameters were compared at 1 year after treatment with baseline (at the start of treatment) and 12-week-posttreatment values. Body mass index (BMI), weight and height Z scores adjusted to sex and age were calculated according to the World Health Organization reference data.

Results: Forty-nine participants (23 boys and 26 girls) completed all the visits. The mean age at 1 year after treatment was 10.9 ± 2.5 years, and all children had undetectable hepatitis C virus RNA at this point. Significant weight and height gains were observed after treatment irrespective of the patients' age and sex. Height Z scores did not vary significantly both at 12 weeks and 1 year after treatment, confirming a normal increase in participants' height. Weight Z scores for 16 children below 10 years of age decreased at 1 year after treatment. BMI Z score values decreased at 12 weeks after treatment compared to the baseline in boys, but no difference was found between 1-year posttreatment and baseline BMI Z scores in both girls and boys.

Conclusions: Results of the PANDAA-PED study showed normal growth up to 1 year after successful treatment with SOF/VEL in children 6-18 years of age. Despite the decrease in BMI Z score in boys observed at 12 weeks after treatment, no differences were found between baseline and 1-year posttreatment values. Our observations confirm the long-term safety of the SOF/VEL treatment in children 6-18 years of age.

MeSH terms

  • Adolescent
  • Antiviral Agents* / therapeutic use
  • Benzimidazoles
  • Benzopyrans
  • Body Mass Index
  • Body Weight / drug effects
  • Carbamates* / therapeutic use
  • Child
  • Drug Combinations
  • Female
  • Hepatitis C, Chronic* / drug therapy
  • Heterocyclic Compounds, 4 or More Rings* / therapeutic use
  • Humans
  • Male
  • Sofosbuvir* / therapeutic use
  • Treatment Outcome

Substances

  • Carbamates
  • Sofosbuvir
  • Antiviral Agents
  • Heterocyclic Compounds, 4 or More Rings
  • velpatasvir
  • Drug Combinations
  • Benzimidazoles
  • Benzopyrans