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Ledipasvir‐Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C
Author(s) -
Schwarz Kathleen B.,
Rosenthal Philip,
Murray Karen F.,
Honegger Jonathan R.,
Hardikar Winita,
Hague Rosie,
Mittal Naveen,
Massetto Benedetta,
Brainard Diana M.,
Hsueh ChiaHsiang,
Shao Jiang,
Parhy Bandita,
Narkewicz Michael R.,
Rao Girish S.,
Whitworth Suzanne,
Bansal Sanjay,
Balistreri William F.
Publication year - 2020
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.30830
Subject(s) - medicine , ledipasvir , sofosbuvir , adverse effect , cirrhosis , gastroenterology , hepatitis c virus , hepatitis c , vomiting , ribavirin , virus , virology
For children under 12 years of age who have chronic hepatitis C virus (HCV) infection, there are currently no approved treatments with direct‐acting antiviral agents. We therefore evaluated the safety and efficacy of ledipasvir‐sofosbuvir in HCV‐infected children aged 3 to <6 years. In an open‐label study, patients 3 to <6 years old chronically infected with HCV genotype 1 (n = 33) or 4 (n = 1) received weight‐based doses of combined ledipasvir‐sofosbuvir as granules (33.75 mg/150 mg for weights <17 kg or 45 mg/200 mg for weights ≥17 kg) for 12 weeks. The primary endpoint was sustained virological response 12 weeks after treatment (SVR12). For the first 14 patients, intensive pharmacokinetic sampling was done on day 10 of treatment. All patients had been infected through perinatal transmission and were treatment naïve. No patients had known cirrhosis. Ten patients (29%) weighed <17 kg. SVR12 was achieved in 97% of patients (33 of 34); the patient who did not achieve SVR12 was 3 years old and discontinued treatment after 5 days because of an adverse event “abnormal drug taste.” The most common adverse events were vomiting (24% of patients), cough (21%), and pyrexia (21%). No patients experienced a serious adverse event. Intensive pharmacokinetic analysis of 13 patients for whom data were evaluable confirmed that the doses selected were appropriate. Conclusion: Ledipasvir‐sofosbuvir was well tolerated and highly effective in children 3 to <6 years old with chronic HCV infection.