Recommendations for Treatment of Chronic Hepatitis Ba
| HBeAg status | Clinical | HBV DNA (IU/mL) | ALT | Recommendation |
|---|---|---|---|---|
| HBeAg-reactive |
Chronic hepatitis Cirrhosis compensated Cirrhosis decompensated | >2 × 104
>2 × 104d >2 × 103 <2 × 103 Detectable Undetectable | ≤2 × ULNc,d
>2 × ULNd <or > ULN >ULN <or > ULN <or > ULN | No treatment; monitor. In pts >40, with family history of hepatocellular carcinoma, and/or ALT persistently at the high end of the twofold range, liver biopsy may help in decision to treat
Treate Treate with oral agents, not PEG IFN Consider treatmentf Treate with oral agentsg, not PEG IFN; refer for liver transplantation Observe; refer for liver transplantation |
| HBeAg-negative | Chronic hepatitis Chronic hepatitis Cirrhosis compensated
Cirrhosis decompensated | ≤2 × 103 >103
>104 >2 × 103 <2 × 103 Detectable Undetectable | ≤ULN 1 to >2 × ULNd
>2 × ULNd <or > ULN >ULN <or > ULN <or > ULN | Inactive carrier; treatment not necessary Consider liver biopsy; treath if biopsy shows moderate to severe inflammation or fibrosis Treath,i Treate with oral agents, not PEG IFN Consider treatmentf Treath with oral agentsg, not PEG IFN; refer for liver transplantation Observe; refer for liver transplantation |
aBased on practice guidelines of the American Association for the Study of Liver Diseases (AASLD). Except as indicated in footnotes, these guidelines are similar to those issued by the European Association for the Study of the Liver (EASL).
bLiver disease tends to be mild or inactive clinically; most such pts do not undergo liver biopsy.
cThis pattern is common during early decades of life in Asian pts infected at birth.
dAccording to the EASL guidelines, treat if HBV DNA is >2 × 103 IU/mL and ALT >ULN.
eOne of the potent oral drugs with a high barrier to resistance (entecavir or tenofovir) or PEG IFN can be used as first-line therapy (see text). These oral agents, but not PEG IFN, should be used for interferon-refractory/intolerant and immunocompromised pts. PEG IFN is administered weekly by subcutaneous injection for a year; the oral agents are administered daily for at least a year and continued indefinitely or until at least 6 months after HBeAg seroconversion.
fAccording to EASL guidelines, pts with compensated cirrhosis and detectable HBV DNA at any level, even with normal ALT, are candidates for therapy. Most authorities would treat indefinitely, even in HBeAg-positive disease after HBeAg seroconversion.
gBecause the emergence of resistance can lead to loss of antiviral benefit and further deterioration in decompensated cirrhosis, a low-resistance regimen is recommended—entecavir or tenofovir monotherapy or combination therapy with the more resistance-prone lamivudine (or telbivudine) plus adefovir. Therapy should be instituted urgently.
hBecause HBeAg seroconversion is not an option, the goal of therapy is to suppress HBV DNA and maintain a normal ALT. PEG IFN is administered by subcutaneous injection weekly for a year; caution is warranted in relying on a 6-month posttreatment interval to define a sustained response, because the majority of such responses are lost thereafter. Oral agents, entecavir or tenofovir, are administered daily, usually indefinitely or until, as very rarely occurs, virologic and biochemical responses are accompanied by HBsAg seroconversion.
iFor older pts and those with advanced fibrosis, consider lowering the HBV DNA threshold to >2 × 103 IU/mL.
Abbreviations: AASLD, American Association for the Study of Liver Diseases; ALT, alanine aminotransferase; EASL, European Association for the Study of the Liver; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; PEG IFN, pegylated interferon; ULN, upper limit of normal.