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Hepatol Commun. 2018 Oct 5;2(11):1311-1319. doi: 10.1002/hep4.1250. eCollection 2018 Nov.

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4.

Author information

1
Division of Gastroenterology, Hepatology, and Nutrition, Texas Children's Hospital and Department of Pediatrics Baylor College of Medicine Houston TX.
2
HELIOS Medical Center Wuppertal, Department of Pediatrics Witten/Herdecke University Wuppertal Germany.
3
AbbVie Inc North Chicago IL.
4
Present address: University of California San Diego School of Medicine San Diego CA.
5
Department of Pediatrics University of Florida College of Medicine and Shands Children's Hospital Gainesville FL.
6
Present address: Division of Gastroenterology Hepatology and Liver Transplantation Florida Hospital for Children Orlando FL.
7
Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital and Department of Pediatrics Harvard Medical School Boston MA.
8
New York-Presbyterian Morgan Stanley Children's Hospital Department of Pediatrics Columbia University Medical Center New York NY.
9
Digestive 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.
10
Cliniques Universitaires Saint-Luc, Université Catholique de Louvain Brussels Belgium.
11
Servei de Pediatria Hospital Sant Joan de Déu y Universitat de Barcelona Barcelona Spain.
12
Seattle Children's Hospital and Department of Pediatrics University of Washington School of Medicine Seattle WA.
13
San Jorge Children's Hospital and University Pediatric Hospital San Juan, Puerto Rico.
14
Present address: PRA Health Sciences Raleigh NC.
15
Department of Pediatrics University of California San Francisco San Francisco CA.

Abstract

In adults, treatment of hepatitis C virus (HCV) infection with ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with or without dasabuvir (DSV) and ±ribavirin (RBV) results in high rates of sustained virologic response (SVR). However, these regimens have not been investigated in adolescents. This ongoing, open-label, phase 2/3 study evaluated the pharmacokinetics, safety, and efficacy of OBV/PTV/r+DSV±RBV treatment for 12 weeks in adolescents infected with HCV genotype (GT) 1 without cirrhosis (part 1) and the safety and efficacy of OBV/PTV/r±DSV±RBV treatment for 12 or 24 weeks in adolescents infected with GT1 or GT4 without cirrhosis or with compensated cirrhosis (parts 1 and 2). Patients were 12-17 years of age and treatment naive or interferon experienced. Treatment regimens were based on HCV GT and cirrhosis status. Endpoints were SVR at posttreatment week 12 (SVR12), adverse events (AEs), and pharmacokinetic parameters. Thirty-eight adolescents were enrolled, 66% were female patients, and 76% were White; 42%, 40%, and 18% of patients had HCV GT1a, GT1b, and GT4 infections, respectively. Median age was 15 years (range, 12-17 years), and 1 patient had cirrhosis. The SVR12 rate was 100% (38/38; 95% confidence interval [CI], 90.8%-100%). No treatment-emergent grade 3 or 4 laboratory abnormalities were reported. No serious AEs occurred on treatment, and no AEs led to study drug discontinuation. The most common AEs were headache (21%), fatigue (18%), nasopharyngitis (13%), pruritus (13%), and upper respiratory tract infection (11%). Intensive pharmacokinetic results showed OBV, PTV, DSV, and ritonavir drug exposures were comparable to those seen in adults. Conclusion: Treatment with OBV/PTV/r±DSV±RBV was well tolerated and highly efficacious in adolescents with HCV GT1 or GT4 infection.

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