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

• Published in: Journal of pediatric gastroenterology and nutrition Vol. 67; no. 1; pp. 86 - 89
• Main Authors: Yakoot, Mostafa, El‐Shabrawi, Mortada H., AbdElgawad, Manal M., Mahfouz, Aml A., Helmy, Sherine, Abdo, Alaa M., El‐Khayat, Hisham R.
• Format: Journal Article
• Language: English
• Published: United States by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology 01.07.2018
• Subjects: adolescents; chronic hepatitis C; daclatasvir; efficacy; safety; sofosbuvir
• ISSN: 0277-2116; 1536-4801
• DOI: 10.1097/MPG.0000000000001968

ABSTRACT 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 (HCV) infection 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 of 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 (EOT) visit. Whereas 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: SOF/DCV combined therapy could be a safe and effective treatment in adolescent patients 12 to 17 years old with chronic HCV genotype 4 infection. (See Video, Supplemental Digital Content, http://links.lww.com/MPG/B348).