Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection

Objectives: Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by The European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus infection (HCV) in adults for all genotypes; however it is still not considered for patients younger than 18 years old. We aimed to test safety and efficacy of SOF/DCV in adolescent patients 12 to 17 years old with chronic HCV, genotype 4 infection. Methods: We conducted a prospective, uncontrolled, open-label multicenter study. A total of 30 chronic HCV infected adolescents, aged from 12 to 17 years old were included and treated with dual SOF/DCV for 12 weeks. Patients were monitored throughout the treatment and follow-up period for safety and efficacy outcome measures including the sustained virologic response 12 (SVR12) rate. Results: The Intention to treat (ITT) SVR12 rate was 29/30 (96.7%; 95% confidence interval (CI): 83.3 – 99.4%). The only patient who did not achieve SVR12 was lost to follow up after showing viral negativity at the end of treatment visit. While all the remaining 29 patients (100%, 95% CI: 88.3 - 100%) who completed the follow up visits achieved SVR12. All patients showed normalized liver enzymes with normal hematological, liver and renal function tests at the end of the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study. Conclusions: Sofosbuvir/Daclatasvir combined therapy could be a safe and effective treatment in adolescent patients 12 to 17 years old with chronic HCV genotype 4 infection. Address correspondence and reprint requests to Dr. Mostafa Yakoot, MD, Green CRC; 27 Green Street 21121, Alexandria, Egypt (e-mail: yakoot@yahoo.com). Received 6 February, 2018 Accepted 7 March, 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). The study protocol was reviewed and approved by the Research Ethics Committee of Faculty of Medicine, Alexandria University (IRB00007555) according to the Declaration of Helsinki. All subjects and their parents/guardians gave written informed consent before any treatment interventions were performed. Disclosures of Conflict of Interest: Mortada El-Shabrawi has nothing to disclose; Hisham El Khayat has nothing to disclose, Manal M AbdElgawad and Aml A Mahfouz have nothing to disclose, Sherine Helmy works and has stocks in Pharco Corporate, Mostafa Yakoot and Alaa M Abdo have conducted clinical trials on Pharco products. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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