Table 4. Approved Treatments for Chronic Hepatitis B
Agent (Trade Name)RouteClassDosageDurationResistanceSide Effects
    Interferon α-2b (Intron A)Subcutaneous5 × 106 IU daily or 10 × 106 IU 3 times weekly3 × 106 IU/m2, 3 times weekly, up to a maximum of 10 × 106 IU weekly*HBeAg-positive: 16−24 weeks
HBeAg-negative: 48 weeks
Influenza-like symptoms, fatigue, headache, malaise, emotional lability (anxiety, irritability)
    Pegylated-interferon α-2a (Pegasys)Subcutaneous180 μg weeklyNot indicated in patients <18 years old48 weeks
Nucleo(s)tide analogs
    ETV (Baraclude)OralNUC0.5 mg daily in NUC-naïve patients
1.0 mg daily in LVD-experienced patients (≥16 years old)
Indicated for patients aged ≥2 years and weighing ≥10 kg
Patients ≤30 kg: weight-based dosing of oral solution
    LVD-naïve: 3–9 mL daily
    LVD-experienced: 6–18 mL daily
Patients >30 kg
    LVD-naïve: 10 mL (0.5 mg) solution or one 0.5-mg tablet daily
    LVD-experienced: 20 mL (1 mg) solution or one 1-mg tablet daily
≥1 year HBeAg-positive: until HBeAg seroconversion* with maintained undetectable HBV DNA (plus ≥6–12 months' consolidation therapy)
HBeAg-negative: until maintained undetectable HBV DNA (plus ≥6–12 months' consolidation therapy)
1% at year 5Negligible
    TDF (Viread)OralNUC300 mg daily (patients ≥12 years)Not indicated for patients <12 years oldNone up to year 5Potential nephrotoxicity
    LdT (Tyzeka; Sebivo)OralNUC600 mg daily (patients ≥16 years)Not indicated for patients <16 years old17% at year 2Negligible
    ADV (Hepsera)OralNUC10 mg daily (patients ≥12 years)Not indicated for patients <12 years old29% at year 5Potential nephrotoxicity
    LVD (Epivir, Zeffix)OralNUC100 mg dailyPatients aged 2–17 years: weight-based dosing, oral solution or tablets; 3 mg/kg daily (maximum 100 mg daily)*24% at year 1
70% at year 5
  • Data compiled from Lok and McMahon,10 European Association for the Study of the Liver clinical practice guidelines,12 US prescribing information for Baraclude (Bristol-Myers Squibb, 2014); Viread (Gilead Biosciences, 2013); Tyzeka (Novartis, 2013); Hepsera (Gilead Biosciences, 2012); Epivir (ViiV Healthcare, 2013); Pegasys (Genentech/Roche, 2014); and Intron A (Merck, 2011).

  • * Use in pediatric patients approved in the United States but not in the European Union. Hepatitis B e antigen (HBeAg) loss and anti-HBe-positivity on 2 occasions 1–3 months apart.

  • Recommended first-line agents.

  • Dose adjustment is required in patients with impaired renal function (creatinine clearance <50 mL/min).

  • ADV, adefovir; ETV, entecavir; HBV, hepatitis B virus; LdT, telbivudine; LVD, lamivudine; NUC, nucleo(s)tide analog; TDF, tenofovir.