Data on the novel coronavirus disease 2019 (COVID-19) in children are limited, and studies from Europe are scarce. We analyzed the clinical severity and epidemiologic aspects of COVID-19 in consecutive children aged 0–18 years, referred with a suspicion of COVID-19 between February 1, and April 15, 2020. RT-PCR on a nasopharyngeal swab was used to confirm COVID-19. 319 children met the criteria of a suspected case. COVID-19 was diagnosed in 15/319 (4.7%) patients (8 male; mean age 10.5 years). All of them had household contact with an infected relative. Five (33.3%) patients were asymptomatic. In 9/15 (60.0%) children, the course of the disease was mild, and in 1/15 (6.7%), it was moderate, with the following symptoms: fever (46.7%), cough (40%), diarrhea (20%), vomiting (13.3%), rhinitis (6.7%), and shortness of breath (6.7%). In the COVID-19-negative patients, other infections were confirmed, including influenza in 32/319 (10%). The clinical course of COVID-19 and influenza differed significantly based on the clinical presentation. In conclusion, the clinical course of COVID-19 in children is usually mild or asymptomatic. In children suspected of having COVID-19, other infections should not be overlooked. The main risk factor for COVID-19 in children is household contact with an infected relative.

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Background: Available real-world data on the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) in pediatric patients are limited. In this prospective, open-label, single-center study, we aimed to present our real-life experience with a fixed dose of LDV/SOF (90/400 mg) for the treatment of chronic hepatitis C (CHC) genotypes 1 and 4 in children aged 12 to 17 years. Methods: We analyzed intention-to-treat (ITT) and per-protocol (PP) rates of sustained virological response (SVR), defined as undetectable HCV viral load at posttreatment week 12, in 37 participants treated with LDV/SOF according to the HCV genotype, baseline liver fibrosis, duration of treatment, and experience of the previous ineffective antiviral treatment. There were 32 patients infected with genotype 1 and 5 with genotype 4. Fourteen (38%) participants were treatment-experienced, two were coinfected with HIV, and three were cirrhotic. Two patients qualified for 24 weeks of therapy, and the remaining 35 received 12 weeks of LDV/SOF treatment. Results: The overall ITT SVR12 rate was 36/37 (97%). One patient was lost to follow-up after week 4 of therapy when his HCV RNA was undetectable. All 36 patients who completed the full protocol achieved SVR (36/36, 100%). PP analyses of SVR12 rates according to the HCV genotype, baseline liver fibrosis, duration of the treatment, and previous ineffective treatment were all 100%. A significant decrease in aminotransferase serum levels was observed in the subsequent weeks of the treatment and at SVR assessment compared to baseline. No serious adverse events were reported. Conclusions: The results of this study confirm previous observations of a suitable efficacy and safety profile of LDV/SOF for the treatment of CHC genotypes 1 and 4 in adolescents.

Background: The aim of this prospective study was to analyze liver fibrosis in teenagers with chronic hepatitis C (CHC) using noninvasive methods. Methods: Thirty-five patients with CHC, 12–17 years of age (mean 14.2 ± 1.8 years; 22/35, 63% male) were included. Most of them (29/35, 83%) were infected vertically, 21/35 (60%) were treatment-naive, 30/35 (86%) were infected with genotype 1 and 5/35 (14%) were infected with genotype 4 HCV. In all patients, evaluation of liver fibrosis was performed using transient elastography (TE) and measurement of the following serum biomarkers: aspartate transaminase-to-platelet ratio index (APRI) and Fibrosis-4 index (FIB-4). Using liver stiffness measurement (LSM) results as a reference, the diagnostic performance of APRI and FIB-4 was assessed by calculating area under the receiver operating characteristics curve. Results: Transient elastography results revealed no or mild fibrosis (F0/1 in METAVIR scale) in 31/35 (89%) patients. In 4/35 (11%) patients, significant fibrosis was observed (F ≥ 2), including 3/35 (9%) with cirrhosis (F4). The median APRI was 0.32, and the median FIB-4 was 0.32. LSM was associated with both APRI and FIB-4 [r = 0.61, 95% confidence interval (CI) 0.35–0.79, P = 0.0001; and r = 0.60, 95% CI 0.32–0.78, P = 0.0002, respectively]. For the diagnosis of significant fibrosis, the area under the receiver operating characteristics (95% CI) for both APRI and FIB-4 was 0.855 (0.695–0.951). APRI, with a cutoff >0.374, predicted significant fibrosis, with 100% sensitivity and 67.7% specificity, whereas FIB-4, with a cutoff >0.402, predicted significant fibrosis, with 75.0% sensitivity and 90.3% specificity. Conclusions: Significant fibrosis, including cirrhosis, may occur in teenagers with CHC. Serum biomarkers (APRI, FIB-4) correlate positively with LSM.

The therapeutic program was carried out thanks to the donation of LDV/SOF provided by the producer (Gilead Sciences Poland Sp. z o.o.). The pharmaceutical company did not have any role in performing the study, nor in writing or approving this article. M.P.Ś. performed the research, designed the research study, collected and analyzed the data, contributed to the interpretation of the data and drafted the article; A.D. and A.O. collected and analyzed the data; M.M. contributed to the study design and critically revised the article; all authors read and approved the final article. The investigation was performed in accordance with the ethical standards in the 1964 Declaration of Helsinki and its later amendments. The local ethics committee at the Medical University of Warsaw approved this study and the treatment protocol for pediatric patients with chronic HCV infection.