Efficacy of Sofosbuvir/Velpatasvir (SOF/VEL) Combination in Children with chronic Hepatitis C: A Prospective Study

Abstract

Objective: To evaluate the efficacy and safety of Sofosbuvir/Velpatasvir (SOF/VEL) combination therapy in children aged 3–12 years with chronic hepatitis C (CHC).

Study Design: Prospective analytical study.

Place and Duration of Study: Department of Paediatric Gastroenterology and Hepatology, Combined Military Hospital, Rawalpindi, Pakistan, from Oct 2023 to Dec 2024.

Methodology: Fifty-eight treatment-naive children (3–12 years) with confirmed CHC infection and normal baseline liver ultrasound were enrolled using non-probability consecutive sampling. Patients with cirrhosis, hepatitis B surface antigen (HBsAg) positivity, or impaired renal function were excluded. All participants received a weight-based fixed dose of Sofosbuvir and Velpatasvir. Treatment response was assessed by hepatitis C virus ribonucleic acid polymerase chain reaction (HCV RNA PCR) at baseline, at the end of treatment (end-of-treatment response), and 12 weeks after completion of therapy (sustained virological response at 12 weeks [SVR12]). Adverse events were monitored prospectively. Data were analysed using R statistical software, and a p-value < 0.05 was considered statistically significant.

Results: The mean age was 7.2±2.5 years, with 53.5% female participants. Genotype 3 was predominant (72.4%). Most individuals had no comorbidities (58.6%), although thalassemia major was relatively frequent (24.1%). Overall, an SVR12 rate of 94.8% (n=55) was achieved. Mean HCV RNA levels declined from 3.39 million IU/mL to 400 IU/mL (p<0.001). Side effects were mostly mild; 62.1% reported none.

Conclusion: Sofosbuvir/Velpatasvir demonstrated excellent efficacy and tolerability in children with CHC, supporting its role as a first-line therapy in paediatric populations.