Sofosbuvir-Based Therapies for Children With Hepatitis C
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on June 18th, 2025
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Hepatitis C treatments that are effective in adults—such as pegylated interferon and ribavirin—have been associated with developmental complications in pediatric populations. Although the World Health Organization recommends the use antiviral, the long-term safety of these therapies in children remains uncertain. To address this gap, a study funded by Gilead Sciences was conducted to evaluate the long-term safety and efficacy of sofosbuvir in children.
This observational study involved 426 children with a mean age of 12 years, of whom 90% had acquired HCV via vertical transmission. All participants received sofosbuvir, an oral antiviral that inhibits the NS5B RNA polymerase of the virus. They were further categorized based on additional agents in their regimen: 1) ribavirin, 2) ledipasvir, 3) velpatasvir, or 4) a combination of velpatasvir and voxilaprevir.
After a median follow-up of 3.7 years, the study found no evidence of impaired growth or delayed sexual development across any treatment group. Despite the promising findings, the study contains several limitations. The observational design inherently restricts causal inference, and the high dropout rate may have introduced bias. Furthermore, imbalanced genotype representation across the groups could have influenced outcomes.
This observational study involved 426 children with a mean age of 12 years, of whom 90% had acquired HCV via vertical transmission. All participants received sofosbuvir, an oral antiviral that inhibits the NS5B RNA polymerase of the virus. They were further categorized based on additional agents in their regimen: 1) ribavirin, 2) ledipasvir, 3) velpatasvir, or 4) a combination of velpatasvir and voxilaprevir.
After a median follow-up of 3.7 years, the study found no evidence of impaired growth or delayed sexual development across any treatment group. Despite the promising findings, the study contains several limitations. The observational design inherently restricts causal inference, and the high dropout rate may have introduced bias. Furthermore, imbalanced genotype representation across the groups could have influenced outcomes.