Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years
Condition: Hepatitis C, Chronic; Children, Only
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional

Summary: 
      Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the
      world map of HCV. Results in adults are promising. FDA approved only two drugs in the
      pediatric age group 12 to 17 years. Younger children are still on the wait list for
      treatment. The current study aimed to treat children aged between 3 and 12 years with half
      the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).
    

Detailed description: 
      The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population
      (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of
      HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general
      population. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.

      Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for
      liver transplant; approximately 170 million people worldwide are chronically infected. There
      is general consensus that HCV elimination is associated with strong and sustained CD4+ and
      CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins,
      however, they are not maintained in patients who develop chronic disease . A variety of
      factors purportedly contribute to the dimi-nished T cell responses observed in chronically
      infected patients, including an im-paired dendritic cell (DC) function.

      The successful development of direct-acting antivirals (DAAs) that are active against
      hepatitis C virus has transformed chronic hepatitis C infection from a con-dition requiring
      complex therapies with unsatisfactory outcomes to one that can be easily treated with few
      contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and
      the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment
      of adults with chronic hepatitis C. Investigation into DAAs for children has been slower.

      For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination
      sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus
      ribavirin for genotype 2 or 3 infection have been described in full-length articles.

      A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in
      Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection.
      Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir
      and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir,
      pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in
      adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir
      plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with
      genotype 4 infection.

      Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity
      to elicit primary T cell responses. Two major subsets of DC can be identified from human
      peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset
      represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.
    

Intervention name(s): Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
Intervention type(s): Drug
Intervention description(s): Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment