Sustained Viral Response in Genotype 4 Chronic HCV Infected Children and Adolescents Treated with Sofosbuvir/Ledipasvir

Objectives: Recently, direct acting antivirals (DAAs), sofosbuvir (SOF) combined with ledipasvir (LED) were approved for treatment of HCV infected children 12 years of age and older or weighting at least 35 kg for all HCV genotypes. The aim of this study was to assess the safety and efficacy of SOF/LED in genotype 4 HCV-infected Egyptian children and adolescents. Methods: This observational study included 40 consecutive HCV infected children aged 12 to 35 kg, both treatment-naive and treatment experienced. All were HBV negative and had normal renal functions and heart rate. Patients received oral fixed dose combination tablet of SOF/LED (400 mg SOF, 90 mg LED [Harvoni®]) once daily for 12 weeks. Potential side effects were recorded at weeks 4, 8 and 12 weeks of treatment. The study primary outcome was sustained virological response 12 weeks after end-of-treatment (SVR 12). Results: The study included 40 children and adolescents, 24 were males (60%); their ages ranged between 11.5 and 17.5 years (mean 13.9 ± 1.5). Baseline viral load ranged between 9630 and 24,600,000 IU/ml. HCV RNA became negative in 39 patients (97.5%) at 4 weeks and in all patients (100%) at weeks 8, 12 and SVR12. Asthenia was the commonest side effect, reported in 52.5% followed by headache in 47.5%. Conclusions: Treatment with all-oral DAAs (SOF/LED) for 12 weeks was well tolerated in Egyptian children and adolescents infected with genotype 4 HCV, with 100% SVR12 and negligible side effects. Address correspondence and reprint requests to Engy Adel Mogahed, MD, 2B Sama City, Katamya, Cairo, 11439, Egypt (E-mail: engy.mogahed@kasralainy.edu.eg) Received 1 May, 2018 Accepted 7 July, 2018 Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). Authors have nothing to declare. No conflict of interest. No funding source. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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