Effects of Sofosbuvir/Ledipasvir Therapy on Chronic Hepatitis C Virus Genotype 4, Infected Children of 3–6 Years of Age

Enas M. Kamal; Mortada El-Shabrawi; Hisham El-Khayat; Mostafa Yakoot; Yehia Sameh; Yasser Fouad; Dina Attia


Liver International. 2020;40(2):319-323. 

In This Article


Patients' Characteristics

This prospective study included 22 chronic HCV patients aged 4.8 ± 0.9 years, with 19 (86%) being men. Microcytic hypochromic anaemia was observed in two children. No cases of liver cirrhosis were observed. The main mode of transmission was vertical transmission through the infected mother. All patients were treatment naïve (Table 1).

Effectiveness of Sofosbuvir/Ledipasvir Combination

The SVR12 rates were 100% in both groups. The early response at Week 4 was 81.8% (95% confidence interval [CI]: 52.3–94.7] vs 90.8% (95% CI: 62.3–98.4) in the 12- and 8-week groups, respectively. At Week 8, the 8-week duration showed a 100% response (95% CI: 74.1%-100%) (EOT), while the 12-week duration showed a 90.8% (95% CI: 62.3–98.4). Adherence to treatment was 100%, and no patients were lost to follow-up (Table 2).

Treatment Safety

Nonspecific side effects were observed in all patients; however, there were no serious adverse effects requiring drug discontinuation and no deaths. In the 8-week group, one patient experienced abdominal pain and one patient had pyrexia. The abdominal pain appeared during the first 4 weeks, resolved without treatment thereafter, and was nonspecific. The pyrexia appeared only in the first few days and resolved with cold fomentations and paracetamol. In the 12-week group, one patient had cough, another patient had diarrhoea and a third patient developed vomiting. The cough appeared during the second dose of the treatment regimen was dry and resolved without treatment. Vomiting was observed in a child aged 3-year old after the first dose due to difficulty in swallowing the tablet and the mother was advised to grind the tablet in juice only. No laboratory abnormalities were observed.