DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Unknown

Conditions: Chronic Hepatitis c

Treatments: Drug: DAAs in Cirrhotics Genotye 1,4,5,6; Drug: Direct Acting Antivirals; Drug: DAAs in Cirrhotics Genotype 2/3

Study type: Interventional

Funder types: Other

Identifiers

NCT03481036

IEC/2018/000323

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Non cirrhotic

Active Comparator group

Description:

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

Treatment:

Drug: Direct Acting Antivirals

Genotype 1,4,5 and 6 with cirrhosis

Active Comparator group

Description:

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

Treatment:

Drug: DAAs in Cirrhotics Genotye 1,4,5,6

Genotype 2 and 3 with Cirrhosis

Active Comparator group

Description:

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

Treatment:

Drug: DAAs in Cirrhotics Genotype 2/3