Evaluation of Liver Fibrosis by FibroScan in β-Thalassemia Children Infected with Hepatitis C Virus Before and After Ledipasvir/Sofosbuvir Therapy

Background: Thalassemic children develop liver fibrosis because of liver iron overload and hepatitis C virus (HCV) infection. Transient elastography (FibroScan) can be a reliable non-invasive method for evaluating liver fibrosis in thalassemic patients. Treatment with ledipasvir/sofosbuvir (LED/SOF) direct acting antiviral agents can significantly affect liver stiffness measurement (LSM) by FibroScan.

Aims: To assess liver fibrosis by non-invasive FibroScan through LSM before and after generic LED/SOF therapy in multi-transfused β-thalassemic children infected with HCV.

Place and Duration of Study: Pediatric Hematology Unit, Tanta University Hospital, from November 2017 to May 2019.

Methodology: Fifty multi-transfused β-thalassemic treatment-naϊve children (aged 12-18 years and weighing ≥35kg) with chronic HCV infection were subjected to clinical evaluation, quantitative HCV PCR assay, FibroScan examination, and calculation of APRI, FIB4 index and AST/ ALT ratio. In addition to standard therapy, generic LED/SOF (90/400 mg) treatment was given for 12 weeks’ duration with follow up for further 12 weeks after end of treatment.

Results: A positive HCV PCR was changed into negative for all studied patients starting from week 4 after treatment. There was highly significant reduction in the LSM values by FibroScan in the studied patients after therapy (p-value <0.001) with median reduction of 19.4 %. The significant reduction in LSM values was particularly prominent in patients with significant (F2) and advanced (F3) liver fibrosis stages as well as cirrhotic patients (F4). There was significant reduction in the values of other non-invasive liver fibrosis markers FIB-4 index, APRI score and AST/ ALT ratio (p-value <0.001, <0.001 and 0.020 respectively) after therapy.

Conclusion: Generic LED/SOF therapy for 12 weeks’ duration resulted in eradication of HCV infection that was associated with significant decrease in LSM by FibroScan particularly those with higher baseline liver fibrosis stages.