Effectiveness and Safety of Sofosbuvir in Treatment-Naive Children with Hepatitis C Infection

Objective: To determine the effectiveness and safety of Sofosbuvir and Ribavirin combination in treatment-naive children with HCV infection. Study Design: An experimental study. Place and Duration of Study: Gastroentrology, Hepatology Department, The Children's Hospital and The Institute of Child Health, Lahore, from January to December 2016. Methodology: HCV PCR positive treatment-naive patients, 5 to 18 years of age, were enrolled by consecutive nonprobability sampling. Clinical features and investigations including complete blood count, bilirubin, ALT, PT and HCV genotyping were done. All patients were started on Sofosbuvir 400 mg once daily and Ribavirin 10-15 mg/kg/day. Patients were followed on 4-weekly basis. PCR was done after 4 weeks; if positive then again at 12 weeks. End of treatment and 12 weeks post treatment PCR was done in all patients. Total duration of therapy was 24 weeks. Computer program SPSS version 20 was used for data analysis. Results: A total of 35 patients with mean age of 10.24 +/- 2.80 years, including 22 boys (62.86%), and 13 girls (37.14%) were included. The most common HCV genotype was genotype 3 encountered in 27 (77.15%), followed by genotype 1 in 6 (17.14%), while 2 (5.71%) patients were untypable. Thirty (85.71%) patients achieved rapid virological response while the rest 5 (14.28%) had early virological response. End-of-treatment PCR was negative in all patients. SVR was achieved by 34 (97.14%) patients. The treatment was well tolerated. Headache was observed in 8 (22.86%) patients, which improved spontaneously. Conclusion: Sofosbuvir and Ribavirin combination is highly effective in HCV genotypes 1 and 3 with no major undesirable short-term side effects.