M H F El-Shabrawi1, N M Kamal1, H R El-Khayat2, E M Kamal3, M M A H AbdElgawad4, M Yakoot5. 1. Pediatric Hepatology, Faculty of Medicine, Cairo University, Cairo, Egypt. 2. Tropical Medicine, Hepatology and Endemic Medicine, Theodore Bilharz Research Institute, Cairo, Egypt. 3. Department of Gastroenterology, Hepatology and Endemic Medicine, Minia University Hospitals, Minia, Egypt. 4. Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt. 5. Green Clinic Research Center (CRC), Alexandria, Egypt.
Abstract
BACKGROUND: No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6- to 12- year old. AIM: To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6- to 12- year old with chronic HCV genotype 4 infection. METHODS: This is a pilot prospective single arm observational open-label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6- to 12- years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12). RESULTS: The intention-to-treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%-99.1%). SVR12 was not assessed in one patient who was lost to follow-up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%-100%) who completed the full protocol and follow-up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities. CONCLUSIONS: This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6- to 12- years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group.
BACKGROUND: No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6- to 12- year old. AIM: To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6- to 12- year old with chronic HCV genotype 4 infection. METHODS: This is a pilot prospective single arm observational open-label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6- to 12- years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12). RESULTS: The intention-to-treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%-99.1%). SVR12 was not assessed in one patient who was lost to follow-up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%-100%) who completed the full protocol and follow-up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities. CONCLUSIONS: This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6- to 12- years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group.
Authors: Jiafeng Li; Julia L Casey; Zoë R Greenwald; Abdool S Yasseen Iii; Melisa Dickie; Jordan J Feld; Curtis L Cooper; Angela M Crawley Journal: Can Liver J Date: 2021-02-24
Authors: Hanaa A El-Araby; Behairy E Behairy; Mohamed A El-Guindi; Nermin M Adawy; Alif A Allam; Ahmad M Sira; Mohamed A Khedr; Ibrahim A Elhenawy; Gihan A Sobhy; Hosam El Din M Basiouny; Menan E Salem; Samira A Abdel-Aziz; Ola A Fouad; Bassam A Ayoub Journal: Hepatol Int Date: 2019-09-12 Impact factor: 9.029
Authors: Emanuele Nicastro; Lorenzo Norsa; Angelo Di Giorgio; Giuseppe Indolfi; Lorenzo D'Antiga Journal: World J Gastroenterol Date: 2021-05-28 Impact factor: 5.742