Table 1.
Approved Antiviral Therapies in Adults and Children
Drug | Dose in Adults1 | Use in Children1 | Pregnancy Category2 | Potential Side Effects2 | Monitoring on Treatment3 |
---|---|---|---|---|---|
Preferred | |||||
Peg-IFN-α-2a (adult) IFN-α-2b (children) |
180 mcg weekly | ≥1 year dose: 6 million IU/m2 three times weekly4 |
C | Flu-like symptoms, fatigue, mood disturbances, cytopenia, autoimmune disorders in adults, anorexia and weight loss in children | Complete blood count (monthly to every 3 months) TSH (every 3 months) Clinical monitoring for autoimmune, ischemic, neuropsychiatric, and infectious complications |
Entecavir | 0.5 mg daily5 | ≥2 years dose: weight-based to 10–30 kg; above 30 kg: 0.5 mg daily5 |
C | Lactic acidosis (decompensated cirrhosis only) | Lactic acid levels if there is clinical concern Test for HIV prior to treatment initiation |
Tenofovir dipovoxil fumarate | 300 mg daily | ≥12 years | B | Nephropathy, Fanconi syndrome, osteomalacia, lactic acidosis | Creatinine clearance at baseline If at risk for renal impairment, creatinine clearance, serum phosphate, urine glucose and protein at least annually Consider bone density study at baseline and during treatment in patients with history of fracture or risks for osteopenia Lactic acid levels if there is clinical concern Test for HIV prior to treatment initiation |
Tenofovir alafenamide | 25 mg daily | -- | There are insufficient human data on use during pregnancy to inform a drug-associated risk of birth defects and miscarriage | Lactic acidosis | Lactic acid levels if clinical concern Assess serum creatinine, serum phosphorus, creatinine clearance, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate Test for HIV prior to treatment initiation |
Non-Preferred | |||||
Lamivudine | 100 mg daily | ≥2 years dose: 3 mg/kg daily to max 100 mg |
C | Pancreatitis Lactic acidosis |
Amylase if symptoms are present Lactic acid levels if there is clinical concern Test for HIV prior to treatment initiation |
Adefovir | 10 mg daily | ≥12 years | C | Acute renal failure Fanconi syndrome Lactic acidosis |
Creatinine clearance at baseline If at risk for renal impairment, creatinine clearance, serum phosphate, urine glucose, and urine protein at least annually Consider bone density study at baseline and during treatment in patients with history of fracture or risks for osteopenia Lactic acid levels if clinical concern |
Telbivudine | 600 mg daily | -- | B | Creatine kinase elevations and myopathy Peripheral neuropathy Lactic acidosis |
Creatine kinase if symptoms are present Clinical evaluation if symptoms are present Lactic acid levels if there is clinical concern |
Dose adjustments are needed in patients with renal dysfunction.
In 2015, the US Food and Drug Administration replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually, and to date only TAF includes these additional data.
Per package insert.
Peg-IFN-α-2a is not approved for children with chronic hepatitis B but is approved for treatment of chronic hepatitis C. Providers may consider using this drug for children with chronic HBV. The duration of treatment indicated in adults is 48 weeks.
Entecavir dose is 1 mg daily if the patient is lamivudine experienced or if they have decompensated cirrhosis.