Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents With Chronic Hepatitis C Infection.
Adolescent
Adolescent Health Services
Antiviral Agents
/ administration & dosage
Benzimidazoles
/ administration & dosage
Drug Administration Schedule
Female
Fluorenes
/ administration & dosage
Hepatitis C, Chronic
/ blood
Humans
Italy
Male
Prospective Studies
Sofosbuvir
Treatment Outcome
Uridine Monophosphate
/ administration & dosage
Viral Load
Journal
Journal of pediatric gastroenterology and nutrition
ISSN: 1536-4801
Titre abrégé: J Pediatr Gastroenterol Nutr
Pays: United States
ID NLM: 8211545
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
pubmed:
25
7
2019
medline:
21
10
2020
entrez:
24
7
2019
Statut:
ppublish
Résumé
Treatment-naïve, noncirrhotic adults with chronic hepatitis C virus genotype 1 infection and with viremia levels <6 million IU/mL could be effectively treated with sofosbuvir/ledipasvir for 8 weeks. The aim of this pilot, prospective, open-label, multicenter study was to evaluate the efficacy and safety of this shortened treatment course in adolescents (≥12 years). The efficacy endpoint was sustained virological response 12 weeks after the end of treatment. Safety was assessed by adverse events and clinical/laboratory data. Fourteen consecutive adolescents (median age 16.5 years, Q1 14.1-Q3 17.4; female 57.1%), vertically infected, were enrolled and treated (June 2018-January 2019). Overall, the end of treatment response and sustained virological response 12 weeks after the end of treatment were 100%. No grade 3 to 4 adverse event or a serious adverse event was observed. Further studies are needed to confirm the optimal efficacy of the shortened 8-week treatment with sofosbuvir/ledipasvir for treatment-naïve, noncirrhotic adolescents with chronic hepatitis C virus genotype 1 infection and pretreatment viremia level < 6 million IU/mL.
Identifiants
pubmed: 31335836
doi: 10.1097/MPG.0000000000002449
doi:
Substances chimiques
Antiviral Agents
0
Benzimidazoles
0
Fluorenes
0
ledipasvir, sofosbuvir drug combination
0
Uridine Monophosphate
E2OU15WN0N
Sofosbuvir
WJ6CA3ZU8B
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM