1. Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a.
- Author
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Rosenthal, Philip, Narkewicz, Michael R., Yao, Betty B., Jolley, Christopher D., Lobritto, Steven J., Wen, Jessica, Molleston, Jean P., Hsu, Evelyn K., Jonas, Maureen M., Zha, Jiuhong, Liu, Li, and Leung, Daniel H.
- Subjects
DRUG tablets ,CHRONIC hepatitis C ,COMBINATION drug therapy ,HETEROCYCLIC compounds ,ANTIVIRAL agents ,HEPATITIS viruses ,HYDROCARBONS ,RIBAVIRIN ,RITONAVIR ,PROLINE ,GENOTYPES ,OXIDOREDUCTASES ,ACYCLIC acids ,AMIDES ,SULFONAMIDES ,CHEMICAL inhibitors - 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.Trial Registration: ClinicalTrials.gov identifier, NCT02486406. [ABSTRACT FROM AUTHOR]- Published
- 2020
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