DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed

Detailed Description
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Consecutive chronic hepatitis C (HCV) infected children [age: ≥12 to <18 years; both treatment-naïve (TN) and treatment-experienced, (TE)] are being enrolled. Genotyping is not recommended for non-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients. Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks, while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients < 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.

Official Title
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Direct Acting Antiviral Agent (DAA) Therapy Is Safe and Efficacious in Pediatric Patients With Chronic Hepatitis C: Real World Data From the Public Health Perspective

Conditions
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Chronic Hepatitis c

Intervention / Treatment
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* Drug: Direct Acting Antivirals
* Drug: DAAs in Cirrhotics Genotype 2/3
* Drug: DAAs in Cirrhotics Genotye 1,4,5,6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C, all genotypes Ages eligible for study: ≥12 to <18 years (Child) Gender eligible for study: either Treatment-naive or treatment-experienced: either Exclusion Criteria: Chronic liver disease of a non-HCV etiology serum creatinine >1.5 mg/dL Evidence of hepatocellular carcinoma or other malignancy Co-infection with hepatitis B virus, or HIV Significant cardiovascular, pulmonary, or neurological disease Evidence of a malabsorption syndrome that could interfere with absorption of orally administered medications History of solid organ or bone marrow transplantation.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non cirrhotic<br>Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day | Drug: Direct Acting Antivirals<br>* Sofosbuvir and Daclatasvir<br>* Other names: DAAs in Non Cirrhotics;|
| Active Comparator: Genotype 1,4,5 and 6 with cirrhosis<br>Sofosbuvir (SOF)+ Ledipasvir (LDV) for 12-weeks + weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and LDV (90 mg) per day | Drug: DAAs in Cirrhotics Genotye 1,4,5,6<br>* Sofosbuvir and Ledipasvir with weight based ribavirin<br>|
| Active Comparator: Genotype 2 and 3 with Cirrhosis<br>Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks+ weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and DCV (60 mg) per day | Drug: DAAs in Cirrhotics Genotype 2/3<br>* Sofosbuvir and Daclatasvir with weight based ribavirin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virological Response (SVR 12) | HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR) | 12 weeks after completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF, Direct acting antiviral agents (DAA), Chronic Hepatitis C, Pediatric population, Adolescent Chronic Hepatitis C