Giuseppe Indolfi1,2, Sabrina Giometto3, Daniele Serranti1, Alessandra Bettiol2, Elisabetta Bigagli2, Salvatore De Masi4, Ersilia Lucenteforte3. 1. Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze, Italy. 2. Department NEUROFARBA, University of Florence, Florence, Italy. 3. Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. 4. Clinical Trial Office, Meyer's Children University Hospital of Florence, Firenze, Italy.
Abstract
BACKGROUND: The effect of direct-acting anti-virals (DAAs) in children and adolescents with chronic hepatitis C virus (HCV) infection is difficult to determine, since few, aged between 3 and 18 years, have been enrolled in clinical trials, and some data come from observational studies. AIM: To summarise the evidence on efficacy and safety of DAAs in children and adolescents with chronic HCV infection. METHODS: We performed a systematic review and meta-analysis of prospective studies on the efficacy and safety of DAAs in subjects <18 years of age. We considered the sustained virological response at post-treatment week 12 as efficacy outcome and adverse events as safety outcome. We considered intervention effect for each study arm by calculating the proportion of sustained virologic response at post-treatment week 12 in subjects receiving all doses of treatment and proportion of adverse events in subjects receiving at least one dose of treatment. Pooled proportions were calculated using the Freeman-Tukey double arcsine transformation. Random effects model was used for all analyses. RESULTS: Among 39 included studies (1796 subjects), the pooled proportion among those receiving all doses of treatment and reaching sustained virologic response at post-treatment week 12 was 100% (95% confidence interval: 100-100). Considering subjects receiving at least one dose of treatment, lowest estimates were reported among children with cirrhosis (83%). Headache and fatigue were the most common adverse events. Serious adverse events were uncommon. CONCLUSIONS: Children and adolescents with chronic HCV infection can be safely treated with DAAs with similar efficacy as reported in adults.
BACKGROUND: The effect of direct-acting anti-virals (DAAs) in children and adolescents with chronic hepatitis C virus (HCV) infection is difficult to determine, since few, aged between 3 and 18 years, have been enrolled in clinical trials, and some data come from observational studies. AIM: To summarise the evidence on efficacy and safety of DAAs in children and adolescents with chronic HCV infection. METHODS: We performed a systematic review and meta-analysis of prospective studies on the efficacy and safety of DAAs in subjects <18 years of age. We considered the sustained virological response at post-treatment week 12 as efficacy outcome and adverse events as safety outcome. We considered intervention effect for each study arm by calculating the proportion of sustained virologic response at post-treatment week 12 in subjects receiving all doses of treatment and proportion of adverse events in subjects receiving at least one dose of treatment. Pooled proportions were calculated using the Freeman-Tukey double arcsine transformation. Random effects model was used for all analyses. RESULTS: Among 39 included studies (1796 subjects), the pooled proportion among those receiving all doses of treatment and reaching sustained virologic response at post-treatment week 12 was 100% (95% confidence interval: 100-100). Considering subjects receiving at least one dose of treatment, lowest estimates were reported among children with cirrhosis (83%). Headache and fatigue were the most common adverse events. Serious adverse events were uncommon. CONCLUSIONS:Children and adolescents with chronic HCV infection can be safely treated with DAAs with similar efficacy as reported in adults.
Authors: Othman AbouBakr; Mohammed Ezz El Regal; Amr Ali Sarhan; Maysaa El Sayed Zaki; Ahmed Noaman Journal: Paediatr Drugs Date: 2022-07-15 Impact factor: 3.930
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