Chronic Hepatitis c Clinical Trial
Official title:
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.
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