Twelve Weeks Sofosbuvir/Daclatasvir in HCV Infected Children Aged 6-18 Years

Safety and Efficacy of Sofosbuvir / Daclatasvir in Children With HCV Aged 6-18 Years

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07905989

Enrollment

Registered

2026-10-30

Start date

2023-12-18

Completion date

2024-07-25

Last updated

2026-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C,Chronic Children, Only

Brief 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 study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.

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 Hepatitis C virus (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. Approximately 90% of Egyptian HCV isolates belong to a single subtype, 4a . Hepatitis C virus is a major cause of chronic liver disease and a principal reason for liver transplant; approximately 170 million people worldwide are chronically infected . The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a condition 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 . Combination therapies with highly effective DAA regimes, such as sofos-buvir/ledipasvir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, sofos-buvir/daclatasvir, sofosbuvir/ribavirin and others, are available for use in children. Most of the DAA regimens have either received or are pending to receive regulatory approval by different medical/drug agencies for use in children and adolescents. Pan-genotypic regimens are also available in children and adolescents, and these regimens can be used while skipping genotype testing. Previous study found that daclatasvir 30 mg once daily was predicted to achieve effective and safe exposures in children 14 to \<35 kg, perhaps down to 10 kg. Other study revealed that combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more was found to be effective and safe . Also other study tested the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group and found that SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children

Interventions

DRUGSofosbuvir/Daclatasvir

Patients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30 mg) daily for 12 weeks. Patients weighted more than or equal to 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60 mg) daily for 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Children with chronic HCV * Age 6-18 y old * Must be able to swallow tablets * Basal HCV viremia less than 6.8 log IU/ml * Treatment -naive * No cirrhosis

Exclusion criteria

* Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV Age below 6 years or above 18 years HCV/HIV coinfection. Patients with HCV infection and HCC Patients with HCV infection and underlying cardiac comorbidities Decompensated patients with HCV Hypoalbuminemia of \<3.5 g/dl International normalized ratio (INR)\>2. Advanced fibrosis scoring by transient elastography (F4 fibroscan) Any concomitant malignancy. Parents' refusal for participation of their children in the study.

Design outcomes

Primary

Measure	Time frame	Description
Side effect 2 Number of patients with Headache	12 weeks	Number of patients with Headache
Side effect 1 Number of patients with fatigue	12 weeks	Number of patients with fatigue
Side effect 3 Number of patients with nausea	12 weeks	Number of patients with nausea
Side effect 4 Number of patients with diarrhea	12 weeks	Number of patients with diarrhea
Side effect 5 Number of patients with insomnia	12 weeks	Number of patients with insomnia
Side effect 6 Number of patients with weakness	12 weeks	Number of patients with weakness
Side effect 7 Number of patients with bradycardia	12 weeks	Number of patients with bradycardia
Side effect 8 Number of patients with cough	12 weeks	Number of patients with cough
Side effect 9 Number of patients with myalgia	12 weeks	Number of patients with myalgia
Side effect 10 Number of patients with dyspnea	12 weeks	Number of patients with dyspnea
Side effect 11 Number of patients with irritability	12 weeks	Number of patients with irritability
Side effect 12 Number of patients with dizziness	12 weeks	Number of patients with dizziness
Side effect 13 Number of patients with depression	12 weeks	Number of patients with depression
Side effect 14 Number of patients with skin rash	12 weeks	Number of patients with skin rash

Secondary

Measure	Time frame	Description
HCV-RNA PCR by the end of therapy	12 weeks	HCV-RNA PCR at week 12
HCV-RNA PCR after 20 weeks for SVR	20 weeks	HCV-RNA PCR at week 20