Guideline approved Antiviral Therapies in Adults and Children for Hepatitis B
| Drug | Dose in Adults | Use in Children | Pregnancy Category | Potential Side Effects | Monitoring on Treatment |
|---|---|---|---|---|---|
| Preferred | |||||
| Peg‐IFN‐α‐2a (adult) IFN‐α‐2b (children) | 180 mcg weekly | ≥1 year dose: 6 million IU/m2three times weeklyd | 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 dailye | ≥2 years dose: weight‐based to 10‐30 kg; above 30 kg: 0.5 mg dailye | C | Lactic acidosis (decompensated cirrhosis only) | Lactic acid levels if there is clinical concern Test for HIV before 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 before 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 a clinical concern Assess serum creatinine, serum phosphorus, creatinine clearance, urine glucose, and urine protein before initiating and during therapy in all patients as clinically appropriate Test for HIV before treatment initiation |
| Nonpreferred | |||||
| 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 a clinical concern Test for HIV before 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 a history of fracture or risks for osteopenia Lactic acid levels if the clinical concern |
| Telbivudine | 600 mg daily | — | B | Creatine kinase elevation and myopathy Peripheral neuropathy Lactic acidosis | Creatine kinase if symptoms are present Clinical evaluation if symptoms are present Lactic acid levels if there is a clinical concern |
- Dose adjustments are needed in patients with renal dysfunction.
- b In 2015, the U.S. 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.
- c Per package insert.
- d 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.
- e Entecavir dose is 1 mg daily if the patient is lamivudine experienced or if they have decompensated cirrhosis.
- Abbreviation: TSH, thyroid stimulating hormone.
| HBeAg Positive | Peg‐IFNa | Entecavirb | Tenofovir Disoproxil Fumarateb | Tenofovir Alafenamidec |
|---|---|---|---|---|
| % HBV‐DNA suppression (cutoff to define HBV‐DNA suppression)d | 30‐42 (<2,000‐40,000 IU/mL) 8‐14 (<80 IU/mL) | 61 (<50‐60 IU/mL) | 76 (<60 IU/mL) | 73 (<29 IU/mL) |
| % HBeAg loss | 32‐36 | 22‐25 | — | 22 |
| % HBeAg seroconversion | 29‐36 | 21‐22 | 21 | 18 |
| % Normalization ALT | 34‐52 | 68‐81 | 68 | — |
| % HBsAg loss | 2‐7 11 (at 3 years posttreatment) | 4‐5 | 8 | 1 |
| HBeAg Negative | Peg‐IFN | Entecavir | Tenofovir Disoproxil Fumarateb | Tenofovir Alafenamidec |
|---|---|---|---|---|
| % HBV‐DNA suppression (cutoff to define HBV‐DNA suppression)e | 43 (<4,000 IU/mL) 19 (<80 IU/mL) | 90‐91 (<50‐60 IU/mL) | 93 (<60 U/mL) | 90 (<29 IU/mL) |
| % Normalization ALTf | 59 | 78‐88 | 76 | 81 |
| % HBsAg loss | 46 (at 3 years post treatment) | 0‐1 | 0 | <1 |
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