DAA Therapy in Pediatric Patients With Chronic Hepatitis C

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

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

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.

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.