AASLD Issues Updated Practice Guidelines for Management of Chronic Hepatitis B

The American Association for the Study of Liver Diseases (AASLD) published a revised version of its "Practice Guidelines for Management of Chronic Hepatitis B" in the September 2009 issue of Hepatology. Key changes are new recommendations for first-line and second-line antiviral therapy, reflecting the latest research on hepatitis B virus (HBV) treatment and the recent approval of tenofovir (Viread) for this indication.

The current revision is the fourth version of the guidelines, which were last updated in 2007. Since the last revision, the U.S. Food and Drug Administration (FDA) has approved tenofovir for treatment of chronic hepatitis B, in addition to its previous indication for HIV disease.

This approval was based on 2 double-blind randomized clinical trials showing that tenofovir was more effective than adefovir (Hepsera).

In a study of hepatitis B "e" antigen (HBeAg) positive patients, treatment with tenofovir for 48 weeks resulted in a significantly higher proportion of participants with undetectable HBV DNA (76% vs 13%), ALT normalization (68% vs 54%), and hepatitis B surface antigen (HBsAg) loss (3% vs 0%) compared with those receiving adefovir. Histological response (74% vs 68%) and HBeAg seroconversion (21% vs 18%) rates were similar.

In the trial of HBeAg negative patients, 48 weeks of tenofovir again resulted in significantly more patients achieving undetectable HBV DNA (93% vs 63%) compared with adefovir recipients. Rates of ALT normalization (76% vs 77%) and histological response (72% vs 69%) were similar.

Based on these findings, the recommendation for first-line oral antiviral therapy has been changed to tenofovir or entecavir (Baraclude), while adefovir has been relegated to second-line status. Interferon also remains a first-line option for patients without cirrhosis.

Since the last guidelines update, however, further information has emerged confirming that entecavir has previously unrecognized activity against HIV. Therefore, entecavir is no longer recommended for HIV-HBV coinfected patients who are being treated only for hepatitis B. Such patients should receive interferon, or perhaps adefovir. (The current DHHS antiretroviral treatment guidelines recommend that HIV-HBV coinfected people who need treatment for hepatitis B should receive a full combination antiretroviral regimen containing drugs with dual activity against both viruses.)

The new hepatitis B guidelines also include recent changes in Centers for Disease Control and Prevention (CDC) recommendations on HBV screening. The CDC now recommends expanded HBV screening for people born in intermediate endemic areas and those who will be receiving cancer chemotherapy or long-term immunosuppressive therapy, which can lead to HBV reactivation.

The full guidelines as they appear in Hepatology are available online.

9/22/09

Reference

AS Lok and BJ McMahon. Chronic hepatitis B: update 2009. Hepatology 50(3): 661-662. September 2009.