Generic sofosbuvir/ledipasvir for the treatment of genotype 4 chronic hepatitis C in Egyptian children (9–12 years) and adolescents
Background/purpose of the study
Worldwide and national efforts are directed against eradication of HCV. The introduction of direct-acting antivirals (DAAs) has changed dramatically the outcome of HCV treatment. In spite of the Food and Drug Administration approval of the oral drugs sofosbuvir (SOF) and ledipasvir (LED) for the treatment of HCV in adolescents more than or equal to 12 years old, sufficient real-world experience is still lacking. The aim of this study was to assess the safety and efficacy of the generic SOF/LED fixed-dose combination 400/90 (400 mg SOF + 90 mg LED) for the treatment of adolescents and children (9–12 years) with chronic hepatitis C (CHC).
In this prospective observational study, 100 cases of genotype 4 CHC were recruited consecutively from those fulfilling the inclusion and exclusion criteria. All cases received the generic fixed-dose combination SOF/LED (400/90), one tablet daily for 12 weeks. All clinical, laboratory, and virologic characteristics were evaluated at base line, and week (W) 2, 4, 8, and 12 of therapy and W12 post-treatment (SVR12).
Recruited children (9–12) and adolescents weighed 28–83 and 31–90 kg, respectively. Eighty cases were naïve and 20 cases were pegylated interferon/ribavirin treatment-experienced. Very rapid virologic response (vRVR) at W2 was 96%, while at W4 response rate was 100% and maintained till the end of treatment and at W12 post-treatment (SVR12). All reported side effects were mild and did not lead to treatment termination and disappeared at W12 post-treatment.
The generic SOF/LED fixed-dose combination is safe and effective in children, 9–12 years, and adolescents with vRVR rate of 96%, 100% EOT response and SVR12.
KeywordsChildren Hepatitis C virus Ledipasvir Sofosbuvir
We acknowledge National Liver Institute, Menofiya University, for funding this work. We would like to thank the residents and nursing staff of the Pediatric Hepatology, Gastroenterology, and Nutrition Department and all physicians and working staff of the Clinical Biochemistry and Radiology Departments for their contribution.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
The study was approved by the Research Ethics Committee of the National Liver Institute, Menofiya University and conforms to the 1964 Declaration of Helsinki and its later amendments. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Informed consent was obtained from parents/guardians of all patients for being included in the study.
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