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Summary of 2004 AASLD Guidelines

AASLD Practice Guidelines  
Chronic Hepatitis B: Update Of Recommendations

Anna S.F. Lok, MD, and Brian J. McMahon, MD

Hepatology March 2004

The first guidelines for the management and treatment of chronic hepatitis B in adults were developed and approved by the American Association for the Study of Liver Diseases (AASLD) in 2001. In light of new advances, these guidelines were updated and published in Hepatology (March 2004).

A summary of the article’s concluding treatment recommendations is provided below.

Recommendations for the Treatment of Chronic Hepatitis B
Summary

[The] careful balance of patient age, severity of liver disease, likelihood of response, and potential adverse events and complications is needed before treatment is initiated. Except for patients with contraindications or previous non-response to specific therapy, either IFN-a, lamivudine, or adefovir may be used as initial therapy for patients with compensated liver disease.

All three medications are FDA approved as first-line therapy. In choosing which antiviral agent to use, consideration should be given not only to long-term safety and efficacy but also the costs of the medication, monitoring tests, and clinic Recommendations for the Treatment of Chronic Hepatitis B

Treatment Recommendations for Chronic HBV 

1. HBeAg-positive patients with elevated ALT levels and compensated liver disease should be observed for 3 to 6 months for spontaneous seroconversion from HBe-antigen to HBe-antibody prior to initiation of treatment.

2. Patients who meet the criteria for chronic hepatitis B should be evaluated further with a liver biopsy (serum HBV DNA >10⁵ copies/mL and persistent or intermittent elevation in aminotransferase levels).

3. Patients in the inactive hepatitis B surface antigen (HBsAg) carrier state should be monitored every 6 to 12 months, as liver disease may become active even after many years of quiescence.

4. Patients with HBeAg-positive chronic hepatitis B:

• ALT greater than 2 times normal, or moderate/severe hepatitis on biopsy. These patients should
  be considered for treatment. Treatment may be initiated with IFN-a, lamivudine or adefovir as the 3 treatments have similar efficacy.
•  ALT persistently normal or minimally elevated (<2 times normal). These patients should not be
  initiated on treatment.
• Children with elevated ALT greater than 2 times normal. These patients should be considered for
  treatment if ALT levels remain elevated at this level for longer than 6 months. Both IFN-a and lamivudine are approved treatments for children with chronic hepatitis B.

5. Patients with HBeAg-negative chronic hepatitis B should be considered for treatment (serum HBV DNA >10⁵ copies/mL, elevated ALT >2 times normal or moderate/severe hepatitis on biopsy). Treatment may be initiated with IFN-a, lamivudine, or adefovir. In view of the need for long-term treatment, IFN-a or adefovir is preferred.

6. Patients who failed to respond to prior IFN-a therapy may be retreated with lamivudine or adefovir if they fulfill the criteria listed above.

7. Persons who develop breakthrough infection while on lamivudine should be treated with adefovir if there is worsening of liver disease, if they had decompensated cirrhosis or recurrent hepatitis B after liver transplant, or if they require concomitant immunosuppressive therapy.

8. Patients with compensated cirrhosis are best treated with lamivudine or adefovir because of the risk of hepatic decompensation associated with IFN-a related flares of hepatitis.

9. Patients with decompensated cirrhosis should be considered for lamivudine treatment. Adefovir may be used as an alternative to lamivudine, although it has not been evaluated as a primary treatment in these patients. If adefovir is used, close monitoring of renal function every 1 to 3 months should be performed. Treatment should be coordinated with transplant centers. IFN-a should not be used in patients with decompensated cirrhosis.

10. For patients with an inactive HBsAg carrier state, antiviral treatment is not indicated.

• AASLD Practice Guidelines
• A Treatment Algorithm for the Management of Chronic HBV in the United States
• EASL International Consensus Conference on Hepatitis B
• NIH Recommendations for Hepatitis B
• A Physician's Guide to Chronic Hepatitis B Treatment

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