Table 8. Recommendations for Treatment of Chronic Hepatitis B (continued)
HBeAg –
HBV DNA (PCR)
> 20,000 IU/mLa
ALT
> 2 × ULN
Treatment Strategy
IFN-α /pegIFN-α, LAM, ADV, ETV, TDF or LdT may be used as initial therapy.
LAM and LdT NOT preferred due to high rate of drug resistance.
ADV NOT preferred due to weak antiviral activity and high risk of resistance after 1st year.
End-point of treatment – not defined. Duration of therapy:
• IFN-α/pegIFN-α: 1 year • LAM/ADV/ETV/LdT/TDF: > 1 year
IFN-α non-responders / contraindications to IFN-α → TDF/ETV.
– –
> 2,000 IU/mL 1-2 × ULN
+/– Detectable
Consider liver biopsy and treat if liver biopsy shows moderate/severe necroinflammation or significant fibrosis.
≤ 2,000 IU/mL ≤ ULN Observe; treat if HBV DNA or ALT ↑.
Cirrhosis Compensated: • HBV DNA > 2,000 IU/mL: Treat: LAM/ADV/ETV/LdT/TDF may be used as initial therapy. ▶ LAM and LdT NOT preferred due to high rate of drug resistance; ADV NOT preferred due to weak antiviral activity and high risk of resistance after 1st year.
• HBV DNA < 2,000 IU/mL: Consider treatment if ALT elevated.
Decompensated: • Coordinate treatment with transplant center. LAM (or LdT) + ADV, TDF or ETV preferred.
• Refer for liver transplant.
+/– Undetectable Cirrhosis Compensated: Observe. Decompensated: Refer for liver transplant.
a
Treatment may be considered in patients with HBV DNA 2,000-20,000 IU/mL, particularly if they are older or have cirrhosis. Although several studies including the REVEAL study showed a correlation between serum HBV DNA and clinical outcomes such as HCC, only patients with one or both samples at baseline and last follow-up with serum HBV DNA > 100,000 copies/mL (> 20,000 IU/mL) had significantly increased risk of HCC. (Chen CJ, et al. JAMA. 2006;295:65-73).
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