Pharmacokinetic evaluation of sofosbuvir/velpatasvir for the treatment of Chronic Hepatitis C in pediatrics aged 3 and older.

Autor: Tuan J; Yale School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, New Haven, CT, USA.; Yale AIDS Program, 135 College St, New Haven, CT, USA., Okoli A; Yale School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, New Haven, CT, USA., Ogbuagu O; Yale School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, New Haven, CT, USA.; Yale AIDS Program, 135 College St, New Haven, CT, USA.
Jazyk: angličtina
Zdroj: Expert opinion on drug metabolism & toxicology [Expert Opin Drug Metab Toxicol] 2023 Dec; Vol. 19 (12), pp. 881-888. Date of Electronic Publication: 2024 Jan 12.
DOI: 10.1080/17425255.2023.2292736
Abstrakt: Introduction: The World Health Organization proposed targets to eliminate hepatitis C virus (HCV) by 2030, aiming to treat ≥80% of people with HCV, decreasing new chronic infections by 90% and liver-related mortality by 65%. While children/adolescents represent a minority of cases, the true burden is underestimated. Advances in drug development have resulted in simplified treatments that are well-tolerated, effective, and pangenotypic in activity. Sofosbuvir/velpatasvir, a combined nucleotide analog NS5B polymerase inhibitor and NS5A inhibitor, respectively, is approved for HCV treatment for individuals ≥3 years, supported by safety data using lower-dose, novel formulations.
Areas Covered: This review discusses chemistry, pharmacokinetics/pharmacodynamics, dosing, efficacy, and safety of sofosbuvir/velpatasvir highlighting pediatric data. Literature review included publications/conference abstracts from PubMed, Google, and Google Scholar. Information from key clinical trials/regulatory approvals is reviewed.
Expert Opinion: Sofosbuvir/velpatasvir is a safe and effective therapy for the treatment of pangenotypic chronic HCV infection with limited cases of virologic relapse and adverse events among pediatric populations aged 3 years and older. However, the tolerability among children less than 6 years could be improved by alternative formulations, if not, shorter treatment durations. An aspirational role of direct-acting antivirals (DAAs) that should be explored is for the prevention of infection in exposed and at-risk pediatric populations.
Databáze: MEDLINE