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

Area of Science:

• Hepatology and Gastroenterology
• Pediatric Infectious Diseases
• Antiviral Therapy Research

Background:

• Hepatitis C Virus (HCV) infection poses a significant health challenge in pediatric populations.
• Limited data exists on the efficacy and safety of direct-acting antiviral (DAA) combinations in treatment-naïve children.
• Understanding optimal treatment regimens is crucial for improving long-term outcomes in pediatric HCV.

Purpose of the Study:

• To evaluate the effectiveness of Sofosbuvir and Ribavirin combination therapy in children with HCV.
• To assess the safety profile of this combination in a pediatric cohort.
• To determine the sustained virological response (SVR) rates in treatment-naïve pediatric patients.

Main Methods:

• An experimental study conducted at The Children's Hospital and The Institute of Child Health, Lahore.
• Thirty-five treatment-naïve pediatric patients (5-18 years) with HCV PCR-positive results were enrolled.
• Patients received Sofosbuvir (400 mg daily) and Ribavirin (10-15 mg/kg/day) for 24 weeks, with PCR monitoring.

Main Results:

• A total of 35 patients (mean age 10.24 ±2.80 years; 62.86% male) were included, with HCV genotype 3 being most prevalent (77.15%).
• All patients achieved end-of-treatment PCR negativity, with 97.14% achieving SVR.
• The combination therapy was well-tolerated, with headache reported in 22.86% of patients, resolving spontaneously.

Conclusions:

• Sofosbuvir and Ribavirin combination therapy is highly effective for treating pediatric HCV genotypes 1 and 3.
• The regimen demonstrated a favorable safety profile with no major short-term adverse events.
• This combination represents a promising therapeutic option for children with HCV infection.