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

Serranti, Daniele*; Dodi, Icilio; Nicastro, Emanuele; Cangelosi, Antonina M.; Riva, Silvia§; Ricci, Silvia||; Bartolini, Elisa*; Trapani, Sandra*; Mastrangelo, Greta*; Vajro, Pietro; D’Antiga, Lorenzo; Resti, Massimo*; Indolfi, Giuseppe*

Journal of Pediatric Gastroenterology and Nutrition: November 2019 - Volume 69 - Issue 5 - p 595–598
doi: 10.1097/MPG.0000000000002449
Short Communication: Hepatology
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ABSTRACT 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.

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

Pediatria Generale e d’Urgenza, Ospedale dei Bambini “Pietro Barilla”, Azienda Ospedaliero-Universitaria di Parma, Parma

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

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

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

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

Address correspondence and reprint requests to Daniele Serranti, MD, Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze, Italy, Viale Gaetano Pieraccini 24, Firenze 50139, Italy (e-mail: daniele.serranti@meyer.it).

Received 11 March, 2019

Accepted 26 June, 2019

The authors did not receive any financial support for this article. The authors did not receive any financial support by the National Institutes of Health (NIH), the Wellcome Trust, and the Howard Hughes Medical Institute (HHMI).

D.S., G.I., E.N., and L.D. are investigators in clinical trials sponsored by Gilead. The sponsors did not play any role in the design, methods, data collection, and analyses, or in the preparation of the present article.

The remaining authors report no conflicts of interest.

© 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,