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Abstract Details
Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a
Adv Ther. 2020 Jul;37(7):3299-3310. doi: 10.1007/s12325-020-01389-9. Epub 2020 May 25.
Philip Rosenthal1, Michael R Narkewicz2, Betty B Yao3, Christopher D Jolley4, Steven J Lobritto5, Jessica Wen6, Jean P Molleston7, Evelyn K Hsu8, Maureen M Jonas9, Jiuhong Zha3, Li Liu3, Daniel H Leung10
Author information
1Department of Pediatrics, University of California, San Francisco, CA, USA. PROSENTH@ucsf.edu.
2Digestive Health Institute, Children's Hospital Colorado and Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA.
3AbbVie Inc., North Chicago, IL, USA.
4Department of Pediatrics, Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, FL, USA.
5NewYork Presbyterian, Morgan Stanley Children's Hospital and Department of Pediatrics, Columbia University Irving Medical Center, New York, NY, USA.
6Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia and Department of Pediatrics, University of Pennsylvania, Philadelphia, PA, USA.
7Department of Pediatrics, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, IN, USA.
8Seattle Children's Hospital and Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
9Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital and Department of Pediatrics, Harvard Medical School, Boston, MA, USA.
10Baylor College of Medicine, Gastroenterology, Hepatology, and Nutrition, Texas Children's Liver Center, Houston, TX, USA.
Abstract
Introduction: To assess the safety, efficacy, and pharmacokinetics of mini-tablet formulations of ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) with or without ribavirin for 12 weeks in children infected with chronic hepatitis C virus (HCV) genotype (GT) 1.
Methods: This is an ongoing, open-label, Phase 2/3 study in children 3-11 years old infected with HCV GT1 who were HCV treatment-naïve and non-cirrhotic. Pediatric mini-tablet formulations of OBV, PTV, ritonavir, and DSV plus ribavirin oral solution were administered for 12 weeks based on body weight. Endpoints included SVR12, adverse events (AEs), and pharmacokinetic parameters.
Results: Overall, 26 children received OBV, PTV, ritonavir, and DSV plus ribavirin; 14 were 3-8 years old and 12 were 9-11 years old; 35% were male; and all had chronic HCV GT1a infection. The SVR12 rate was 96% (25/26; 95% CI 81.1-99.3), with 1 child failing to achieve SVR12 due to non-adherence and treatment discontinuation. Treatment-emergent AEs of Grade ≥ 3 occurred in 3 children; 2 events in 1 child were considered serious; and none were considered treatment-related. No AEs led to discontinuation of study treatment. The most common AEs were headache (27%), fatigue (23%), pyrexia (19%), and vomiting (19%). Pharmacokinetic results showed mini-tablet formulations of OBV, PTV, DSV, and ritonavir drug exposures were comparable to the adult formulation.
Conclusion: The mini-tablet combination of OBV, PTV, ritonavir, and DSV plus ribavirin to treat HCV GT1a infection for 12 weeks was highly effective and suitable in children 3-11 years of age.