NCCVH Guidelines for Hepatitis C Therapy for Children and Adolescents

(12-18 years or ≥26 Kg)

April 2023

Inclusion criterion: HCV RNA positivity

• The test result should be within a maximum period of 6 months prior to therapy.
• If the patient had received HCV antiviral therapy during this period, a new test should be performed.
• Age 12-18 years OR weight:
• ≥ 26 kg for sofsobuvir plus daclatasvir regimen.
• ≥ 30 kg for sofsobuvir plus velpatasvir regimen.

Exclusion criteria

• Refusal of the legal guardian to sign an informed consent for treatment.
• Pregnancy or inability to use effective contraception.
• If there is any drug-drug interaction with concomitant medications.
• Hepatocellular Carcinoma (HCC), except after a period of 6 months of treating HCC by a potentially curative intervention, when no tumor activity is detected (this means two negative consecutive imaging), a committee should review the patient’s necessity to start direct acting antivirals (DAAs).

Precautions before starting treatment

• Check HCV risk factors and treatment history.
• Ensure that the child is capable of swallowing tablets.
• Married adolescent females should have a recent negative pregnancy test.
• Check medications received by the patient for possible drug-drug interactions.
• Family counseling: family screening is advised and positive eligible family members must be treated at the same time.

Patients to be referred to the higher committee

• Previous DAAs exposure with no response or relapse.
• Decompensated cirrhosis (Child B and C; Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
• Patients (children and adolescents) undergoing chemotherapy or immunosuppressive therapy.
• Co-infection with Hepatitis B (HBV).
• Inherited or acquired chronic liver disease.
• Bradycardia or any history of cardiac disease.
• Renal disease patients: if the estimated glomerular filtration rate (eGFR) is <30 ml/min/1.73 m2 or on regular renal dialysis.
• Frequent blood transfusion recipients.
• Poorly controlled diabetes mellitus.
• Potential drug-drug interaction.

Recommended Drug and Dose

Sofosbuvir (SOF) 400 mg tablet plus daclatasvir (DAC) 60 mg tablet orally once daily with food (in the morning) for 12 weeks.

OR

Fixed dose combination of sofosbuvir (SOF) 400 mg / velpatasvir (VEL) 100 mg tablet orally once daily with food (in the morning) for 12 weeks.

Cirrhosis Exclusion

• Ultrasound examination.
• Fibroscan examination.
• FIB-4 scoring system.
• APRI scoring system.

Precautions During Treatment

• Vomiting
  • Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken.
  • If vomiting occurs more than 5 hours after dosing, no additional dose is required.
• Missed dose
  • If the missed dose is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and the next dose at the usual time.
  • If it is after 18 hours, patients should be instructed to skip this dose and take the next dose at the usual time.
• Renal impairment
  • Sofosbuvir-containing regimens could be used without dose adjustment in patients with renal disease, including those with an eGFR ≤30 ml/min and those on dialysis.
• Hepatic impairment
  • No dose adjustment of SOF plus DAC is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).
  • Safety and efficacy of SOF plus DAC have been established in patients with decompensated cirrhosis.
  • Duration of therapy is extended to 24 weeks in advanced cirrhosis.
• Hepatitis C virus/Hepatitis B virus co-infection
  • HBV reactivation has been reported during or after treatment with DAAs.
  • HBV screening (HBsAg) should be performed in all patients before initiation of treatment.
  • HCV/HBV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to the clinical guidelines.

Precautions After the End of Treatment

• Sustained Virological Response (SVR), no-response, and relapse should be documented.
• Patients with advanced fibrosis and cirrhosis need lifelong follow-up and screening for hepatocellular carcinoma according to guidelines.
• HBV vaccination is initiated in those who did not receive the vaccine during childhood.