Red Flags
- Acute liver failure on chronic hepatitis B (jaundice, INR ≥1.5, encephalopathy) — emergency transplant centre referral; immediate antiviral[1]
- Hepatocellular carcinoma identified on surveillance — multidisciplinary hepatobiliary meeting; multiphasic CT or MRI[1]
- Reactivation during immunosuppression (rising HBV-DNA or ALT) — start nucleos(t)ide analogue immediately, do not wait for hepatitis[1]
- HBeAg-positive or HBV-DNA >200,000 IU/mL in pregnancy — start tenofovir at week 24–28 to prevent vertical transmission[1]
First-line treatment
Interventions
- Simplified WHO 2024 treatment criteria[1]Treat all adults with chronic HBV who have any of: significant fibrosis (APRI >0.5 or transient elastography ≥7 kPa) OR persistent ALT >ULN OR HBV-DNA >2000 IU/mL OR cirrhosis OR co-infection HIV/HCV/HDV OR family history of HCC OR extrahepatic manifestations OR pregnancy with HBV-DNA >200,000 IU/mL
- Universal infant immunisation[1]Hepatitis B birth-dose vaccine within 24 hours; complete schedule per UIP; closes the principal route of vertical transmission in high-burden settings
- Vertical transmission prevention[1]HBeAg-positive or HBV-DNA >200,000 IU/mL: start tenofovir at week 24–28 of pregnancy; HBIG + birth-dose vaccine to neonate within 12 h; complete vaccination series; check infant HBsAg/anti-HBs at 9–12 months
- HCC surveillance[1]Ultrasound + AFP every 6 months for cirrhosis at any HBV-DNA level; non-cirrhotic Asian men >40 or women >50; family history of HCC; persistent ALT elevation
- Antiviral prophylaxis for immunosuppression[1]All HBsAg-positive patients receiving anti-CD20 (rituximab), corticosteroids ≥10 mg prednisolone equivalent for ≥4 weeks, BMT, or solid organ transplant — start TDF/TAF/entecavir before therapy and continue ≥12 months after immunosuppression ends
First-line drug therapy
| Drug | Class | Adult | Paediatric | Notes |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate (TDF)[1] | Nucleotide analogue reverse transcriptase inhibitor | 300 mg PO once daily | ≥12 years and ≥35 kg: 300 mg daily | WHO-preferred first-line including pregnancy (most safety data); high genetic barrier to resistance; monitor renal tubular and bone effects with prolonged use; widely available |
| Tenofovir alafenamide (TAF)[1] | Nucleotide analogue reverse transcriptase inhibitor | 25 mg PO once daily | ≥12 years and ≥35 kg: 25 mg PO once daily | Alternative; preferred over TDF in CKD G3+, osteoporosis, or pre-/post-transplant; less widely available than TDF in many programmes |
| Entecavir[1] | Nucleoside analogue reverse transcriptase inhibitor | 0.5 mg PO once daily on empty stomach (1 mg if lamivudine-resistant or decompensated cirrhosis) | ≥2 years weight-based per package insert | First-line alternative; high genetic barrier; renal dose adjustment; not preferred in pregnancy due to limited data |
Tenofovir disoproxil fumarate (TDF)[1]
Nucleotide analogue reverse transcriptase inhibitor
- Adult
- 300 mg PO once daily
- Paediatric
- ≥12 years and ≥35 kg: 300 mg daily
WHO-preferred first-line including pregnancy (most safety data); high genetic barrier to resistance; monitor renal tubular and bone effects with prolonged use; widely available
Tenofovir alafenamide (TAF)[1]
Nucleotide analogue reverse transcriptase inhibitor
- Adult
- 25 mg PO once daily
- Paediatric
- ≥12 years and ≥35 kg: 25 mg PO once daily
Alternative; preferred over TDF in CKD G3+, osteoporosis, or pre-/post-transplant; less widely available than TDF in many programmes
Entecavir[1]
Nucleoside analogue reverse transcriptase inhibitor
- Adult
- 0.5 mg PO once daily on empty stomach (1 mg if lamivudine-resistant or decompensated cirrhosis)
- Paediatric
- ≥2 years weight-based per package insert
First-line alternative; high genetic barrier; renal dose adjustment; not preferred in pregnancy due to limited data
Safety-net
- Do not stop antiviral therapy without specialist supervision — discontinuation can trigger flares including life-threatening hepatitis[1]
- Family members and sexual partners should be tested and vaccinated if not immune; avoid sharing razors, toothbrushes, needles[1]
- Yellowing of eyes/skin, abdominal swelling, confusion, or vomiting blood — same-day medical review (cirrhosis decompensation)[1]
Referral criteria
- All chronic HBsAg-positive patientsHepatology or primary-care HBV programme for staging and treatment decision under simplified WHO criteria[1]
- Cirrhosis, decompensation, HCC, or transplant evaluationHepatology and transplant centre[1]
- HDV co-infection (anti-HDV positive with HDV-RNA detectable)Specialist hepatology — bulevirtide or interferon-based therapy[1]
- Pregnancy with chronic HBV and high viraemiaJoint hepatology and obstetric clinic by week 24[1]
Clinical summary
Diagnosis, simplified treatment criteria, and primary care–led management of chronic hepatitis B; HBV elimination targets in high-prevalence settings.