Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

Mansoura University Children Hospital

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05091008

MansouaUCH0322

Details and patient eligibility

About

Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influence their quality of life. Many efforts have been directed toward the investment of effective drugs with high safety profiles and with oral administration for better compliance. The development of a new direct-acting antiviral (DAA) made it possible to achieve these goals.

Full description

The calculated sample size of the study was ....participants at 5% level of significance and 80 % power, using the following formula:

N= (Z1-α/2+Z1-β) 2 σ1* σ2 / δ 2 This study aims to evaluate the safety and efficacy of the combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infections.

Patients will receive Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at a fixed time with or without food for 12 weeks. Visits will be arranged at 4, 8, and 12 weeks. Patients will have easy access to the pediatric hepatology unit and the treating physician if any urgent problem happens in between the visits.

The SPSS software version 24, SPSS was used for data processing

Enrollment: 50 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • Chronic HCV infection (≥ 6 months).
  • Weighing at least 35 kg.
  • Treatment-naïve children with chronic HCV infection without cirrhosis or with compensated cirrhosis.
  • Parent or legal guardian must provide written informed consent.

• Exclusion Criteria:

  • Patients with comorbidity of chronic medical illness (decompensated heart disease, severe renal impairment (GFR < 30) or ESRD, uncontrolled DM).
  • Concomitant HBV or HIV infection.
  • Medications (Amiodarone, beta-blockers).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

HCV without co-morbidities

Active Comparator group

Description:

Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks

Treatment:

Drug: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

HCV with co-morbidities

Active Comparator group

Description:

Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks

Treatment:

Drug: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet