Sofosbuvir/velpatasvir for the treatment of hepatitis C in pediatric patients
Chiara Rubino1, Sandra Trapani2, Giuseppe Indolfi1,3
1Pediatric And Liver Unit, Meyer Children's University Hospital Of Florence, Florence, Italy.
Insights
Sofosbuvir/velpatasvir offers a safe and effective treatment for chronic hepatitis C virus infection in children. This direct-acting antiviral combination shows promise for expanded pediatric use, though access remains a challenge globally.
Area of Science:
- Hepatology
- Virology
- Pediatric Infectious Diseases
Background:
- Sofosbuvir/velpatasvir is a direct-acting antiviral combination with pangenotypic activity for hepatitis C virus (HCV) infection.
- It received approval for children aged 6-17 years in 2020 and for ages 3-5 years in June 2021.
- Limited access to direct-acting antivirals is a significant issue, particularly in low and middle-income countries.
Purpose of the Study:
- To review the pharmacokinetics, clinical efficacy, tolerability, and safety of sofosbuvir/velpatasvir in pediatric populations.
- To explore the current and potential applications of sofosbuvir/velpatasvir for treating chronic hepatitis C virus infection in children and adolescents.
Main Methods:
- Literature search of PUBMED and EMBASE databases.
- Inclusion of citations from references of available literature and ClinicalTrials.gov.
- Focus on pharmacokinetics, clinical efficacy, tolerability, and safety data.
Main Results:
- Sofosbuvir/velpatasvir demonstrates favorable pharmacokinetics, efficacy, tolerability, and safety profiles in children and adolescents.
- Five direct-acting antiviral combinations, three with pangenotypic activity, are now approved for pediatric use.
- No significant differences in efficacy or safety have been reported among these approved combinations.
Conclusions:
- Sofosbuvir/velpatasvir is a valuable treatment option for chronic hepatitis C virus infection in children and adolescents.
- Continued research and improved access are crucial to address treatment limitations, especially in resource-limited settings.
Abstract:
Introduction: Sofosbuvir/velpatasvir is a combination of direct-acting antivirals with pangenotypic activity for treatment of chronic hepatitis C virus infection. It was approved in 2020 for use in children aged 6-17 years and in June 2021 by the United States Food and Drug Administration for the age group 3-5 years.Areas covered: A literature search of PUBMED and EMBASE was conducted on April 30th and updated on June 10th. Other citations were identified in references of available literature and from ClinicalTrials.gov. The aim of the present research was to outline and discuss the pharmacokinetics, clinical efficacy, tolerability and safety of sofosbuvir/velpatasvir, exploring its actual and potential use in children and adolescents with chronic hepatitis C virus infection.Expert opinion: Five combinations of direct-acting antivirals, of whom three with pangenotypic activity, are now approved for children. No major differences in efficacy and safety profile have been described. Limited access to treatment still is a major issue, especially in low and middle-income countries.
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