ABSTRACT
BACKGROUND: Chronic hepatitis C (CHC) is a health burden with consequent morbidity and mortality. Liver biopsy is the gold standard for evaluating fibrosis and assessing disease severity and prognostic purposes post-treatment. Noninvasive alternatives for liver biopsy such as transient elastography (TE) and diffusion-weighted magnetic resonance imaging (DW-MRI) are critical needs. AIM: To evaluate TE and DW-MRI as noninvasive tools for predicting liver fibrosis in children with CHC. METHODS: This prospective cross-sectional study initially recruited 100 children with CHC virus infection. Sixty-four children completed the full set of investigations including liver stiffness measurement (LSM) using TE and measurement of apparent diffusion coefficient (ADC) of the liver and spleen using DW-MRI. Liver biopsies were evaluated for fibrosis using Ishak scoring system. LSM and liver and spleen ADC were compared in different fibrosis stages and correlation analysis was performed with histopathological findings and other laboratory parameters. RESULTS: Most patients had moderate fibrosis (73.5%) while 26.5% had mild fibrosis. None had severe fibrosis or cirrhosis. The majority (68.8%) had mild activity, while only 7.8% had moderate activity. Ishak scores had a significant direct correlation with LSM (P = 0.008) and were negatively correlated with both liver and spleen ADC but with no statistical significance (P = 0.086 and P = 0.145, respectively). Similarly, histopathological activity correlated significantly with LSM (P = 0.002) but not with liver or spleen ADC (P = 0.84 and 0.98 respectively). LSM and liver ADC were able to significantly discriminate F3 from lower fibrosis stages (area under the curve = 0.700 and 0.747, respectively) with a better performance of liver ADC. CONCLUSION: TE and liver ADC were helpful in predicting significant fibrosis in children with chronic hepatitis C virus infection with a better performance of liver ADC.
ABSTRACT
BACKGROUND/PURPOSE OF THE STUDY: Worldwide and national efforts are directed against eradication of HCV. The introduction of direct-acting antivirals (DAAs) has changed dramatically the outcome of HCV treatment. In spite of the Food and Drug Administration approval of the oral drugs sofosbuvir (SOF) and ledipasvir (LED) for the treatment of HCV in adolescents more than or equal to 12 years old, sufficient real-world experience is still lacking. The aim of this study was to assess the safety and efficacy of the generic SOF/LED fixed-dose combination 400/90 (400 mg SOF + 90 mg LED) for the treatment of adolescents and children (9-12 years) with chronic hepatitis C (CHC). METHODS: In this prospective observational study, 100 cases of genotype 4 CHC were recruited consecutively from those fulfilling the inclusion and exclusion criteria. All cases received the generic fixed-dose combination SOF/LED (400/90), one tablet daily for 12 weeks. All clinical, laboratory, and virologic characteristics were evaluated at base line, and week (W) 2, 4, 8, and 12 of therapy and W12 post-treatment (SVR12). RESULTS: Recruited children (9-12) and adolescents weighed 28-83 and 31-90 kg, respectively. Eighty cases were naïve and 20 cases were pegylated interferon/ribavirin treatment-experienced. Very rapid virologic response (vRVR) at W2 was 96%, while at W4 response rate was 100% and maintained till the end of treatment and at W12 post-treatment (SVR12). All reported side effects were mild and did not lead to treatment termination and disappeared at W12 post-treatment. CONCLUSION: The generic SOF/LED fixed-dose combination is safe and effective in children, 9-12 years, and adolescents with vRVR rate of 96%, 100% EOT response and SVR12.