AN OPEN LABEL, UN-CONTROLLED TRIAL OF SOFOSBUVIR AND RIBAVIRIN COMBINATION THERAPY IN PLACE OF INTERFERON THERAPY IN CHILDREN WITH UNTREATED HEPATITIS C INFECTION

Objective: To determine the safety and effectiveness of sofosbuvir and ribavirin combination therapy in children with untreated HCV infection. Method: this is an experimental study or open labelled un-controlled trial conducted at hepatology department of Children hospital, Lahore and the Institute of Child Health, Lahore from January to December 2016. PCR positive, untreated hepatitis C infected children of age group 5 to 18 years were included in study by following consecutive non probability sampling technique. Signs, symptoms were noted and investigations (blood CP, PT, billirubin, serum ALT and PCR) were performed. Sofosbuvir 400mg 24 hourly and ribavirin 10-15mg/kg/24 hours were given to all patients, treatment duration was twenty four weeks. Patients were followed up with 4 weeks interval after treatment initiation.PCR was performed at 4 weeks duration and was repeated at 12 weeks, if positive. PCR was repeated at completion of treatment and 12 weeks after that. To analyse data SPSS version 20 was used. Results: 35 patients were included in study with age group 10.24±2.80 years amongst which 22(62.86%) were males and 13(37.14%) were females. The commonest HCV genotype was 3, observed in 27(77.15%) patients and genotype 1 was second most common, observed in 6(17.14%) patients, while 2(5.71%) patients were untypeable. Rapid virological response and early virological response was achieved by thirty (85.71%) and five (14.28%) patients, respectively. All patients well tolerated treatment and were PCR negative at the treatment completion. Eight (22.86%) patients suffered headache, but showed rapid recovery. Keywords: Hepatitus C virus, Untreated, children, sofosbuvir, ribavirin