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

Autor: Yakoot M; Internal medicine and Hepatology, Green CRC, Alexandria., El-Shabrawi MH; Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo., AbdElgawad MM; Paediatric Hepatology Department, Alexandria Faculty of medicine., Mahfouz AA; Paediatric Hepatology Department, Alexandria Faculty of medicine., Helmy S; Innovations & Research, Pharco Corporation., Abdo AM; Tropical medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria., El-Khayat HR; Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo, Egypt.
Jazyk: angličtina
Zdroj: Journal of pediatric gastroenterology and nutrition [J Pediatr Gastroenterol Nutr] 2018 Jul; Vol. 67 (1), pp. 86-89.
DOI: 10.1097/MPG.0000000000001968
Abstrakt: 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).
Databáze: MEDLINE
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