Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents With Chronic Hepatitis C Infection.


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
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

Pagination

595-598

Auteurs

Daniele Serranti (D)

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze.

Icilio Dodi (I)

Pediatria Generale e d'Urgenza, Ospedale dei Bambini "Pietro Barilla", Azienda Ospedaliero-Universitaria di Parma, Parma.

Emanuele Nicastro (E)

Paediatric Hepatology, Gastroenterology and Transplantation, Hospital Papa Giovanni XXIII, Bergamo.

Antonina M Cangelosi (AM)

Pediatria Generale e d'Urgenza, Ospedale dei Bambini "Pietro Barilla", Azienda Ospedaliero-Universitaria di Parma, Parma.

Silvia Riva (S)

Unità di Epatologia Pediatrica e Trapianto di Fegato ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo.

Silvia Ricci (S)

Immunology Division, Section of Pediatrics, Department of Health Sciences, University of Florence and Meyer Children's University Hospital of Florence, Firenze.

Elisa Bartolini (E)

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze.

Sandra Trapani (S)

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze.

Greta Mastrangelo (G)

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze.

Pietro Vajro (P)

Dipartimento di Medicina, Chirurgia e Odontoiatria "Scuola Medica Salernitana", Università di Salerno, Salerno, Italy.

Lorenzo D'Antiga (L)

Paediatric Hepatology, Gastroenterology and Transplantation, Hospital Papa Giovanni XXIII, Bergamo.

Massimo Resti (M)

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze.

Giuseppe Indolfi (G)

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze.

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Classifications MeSH