Oral

Background/aims:
Prevalence of chronic HCV infection (CHI) in thalassemics is 8–50%1. The Govement of India’s National Viral Hepatitis Control Program (NVHCP) does not recommend treatment in pediatric patients with CHI2. We evaluated safety and efficacy of sofosbuvir plus daclatasvir as a pan-genotypic regimen in thalassemic children (6-17 years old) with CHI.

Methods:
This was a single-center, open label, single arm, prospective, interventional study. Inclusion criteria: thalassemia children (6-17 years) with CHI and detectable viral load. Everyone received sofosbuvir and daclatasvir for 12 weeks (Children 6-11 years age (group A): sofosbuvir 200 mg and daclatasvir 30 mg once daily; Adolescents (Group B, 12-17 years age): Sofosbuvir 400 mg and Daclatasvir 60 mg once daily). The primary efficacy outcome was SVR12. Safety of treatment was assessed regularly.

Results:
Total 45 patients in group A and 25 in group B were included. Two major genotypes and five subtypes were found. Genotype 3 (n=25, 74.3%) was the major prevalent strain, followed by Genotype 1 (n=10, 25.6 %), and subtype characterization showed 3a (n=24, 61.53%), 1b (n=6, 15.38%), 1c (n=4, 10.25%), 3b (n=4, 10.25%) and 3g (n=1, 2.5%). Efficacy of treatment(SVR12): Group A: 44 patients completed treatment (one had drug induced rash, which improved on stopping treatment), one failed to achieve RVR & SVR12, SVR12 in the intention to treat analysis was 43/45(95.5%) and SVR12 in the per-protocol was 43/44 (97.7%). Group B: all completed treatment and achieved SVR 12(100%). In both groups ALT/AST improved after treatment. ALT showed a significant decrease from baseline (Group A: 147U/L to 68U/L, p<0.001; Group B: 121U/L to 6U/L, p<0.004).

Conclusions:
Our study showed efficacy & safety of sofosbuvir and daclatasvir in children aged 6-17 years. This data provides evidence to incorporate treatment for children with CHI in national guidelines, thus aiming its elimination from low-middle income countries.