Part 1 of the DORA study, a 2019 international clinical trial of glecaprevir and pibrentasvir (G/P) treatment in adolescents with chronic hepatitis C virus (HCV) infection, demonstrated high efficacy and safety. However, few reports have considered real-world experience with G/P treatment in adolescents with chronic HCV. The present prospective multicenter study assessed real-world efficacy and safety of G/P treatment in Japanese adolescents with chronic HCV.
Subjects between 12 and 17 years old who were treatment-naïve or previously managed with interferon-based regimens were prospectively enrolled and treated with G/P (300 mg/120 mg) once daily for 8 or 12 weeks. The primary efficacy endpoint was sustained virologic response at 12 weeks after treatment completion (SVR12). Adverse effects and laboratory abnormalities were assessed.
Twenty-five Japanese patients (15 female) were enrolled from 13 pediatric centers in Japan. Median age was 13 years (range 12–17). Numbers of patients with genotypes 1b, 2a, 2b, and 2b/1b were 6, 12, 6, and 1, respectively. Twenty-two were treatment-naïve, while three had experienced interferon-based treatments. All patients completed G/P treatment (24 for 8 weeks and 1 for 12). Twenty-four achieved SVR12 (96%). Most adverse events were mild. None were serious. G/P significantly decreased serum alanine aminotransferase, γ‐glutamyltransferase, and Wisteria floribunda agglutinin-positive Mac-2-binding protein concentrations. No negative effects on growth or maturation were apparent at 12 weeks.
Under real-world conditions, G/P treatment of Japanese adolescents with chronic HCV was highly efficacious and well tolerated.
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Aspartate aminotransferase-to-platelet ratio index
Body mass index
Glecaprevir and pibrentasvir
Hepatitis C virus
Human immunodeficiency virus-1
Wisteria floribunda Agglutinin-positive Mac-2-binding protein
Sustained virologic response at posttreatment week 12
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The authors thank Shintaro Ogawa at the Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences for assisting with RASs analysis. We also thank all participating patients, their families, and their physicians for collaborating in data collection.
This work was supported by the Research Program on Hepatitis from the Japanese Agency for Medical Research and Development, AMED (22fk0210068h0003 and 22fk0210103).
Conflict of interest
Tatsuki Mizuochi reports personal fees from AbbVie GK. Yasuhito Tanaka reports personal fees from Gilead Sciences Inc., Fujirebio Inc., and AbbVie GK; research grants from Gilead Sciences, Inc., Fujirebio Inc., AbbVie GK, and Board of Trustees of the Leland Stanford Junior University.
Ethics approval and consent to participate
This study protocol complied with the ethical guidelines of the Declaration of Helsinki and was approved by the Ethics Committee of Kurume University and its counterparts at other participating centers.
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Mizuochi, T., Iwama, I., Inui, A. et al. Real-world efficacy and safety of glecaprevir/pibrentasvir in Japanese adolescents with chronic hepatitis C: a prospective multicenter study. J Gastroenterol 58, 405–412 (2023). https://doi.org/10.1007/s00535-023-01968-x