Drug & Device Development

Antivirals effective against HBV post liver transplant, without HBIG

Last Updated: 2013-05-07 16:25:18 -0400 (Reuters Health)

By David Douglas

NEW YORK (Reuters Health) - After liver transplantation for hepatitis B, antiviral prophylaxis with oral nucleoside and nucleotide analogues is effective without use of hepatitis B immune globulin (HBIG), Chinese researchers say.

Dr. James Fung told Reuters Health by email "The most important clinical implication for the current study is the excellent long term outcome and survival that is achieved in the absence of HBIG."

"Clinicians may have been uneasy previously because of fear of hepatitis B recurrence in the long term without HBIG, even with recent studies showing the efficacy of new potent antiviral agents with high barriers to resistance," he added.

Dr. Fung of Queen Mary Hospital, Hong Kong and colleagues followed 362 patients transplanted between 2003 and 2011 - including 49% taking lamivudine, 38% on entecavir, and 12% on combination therapy, mainly with lamivudine and adefovir. None of the patients received HBIG.

As reported April 30th online in The American Journal of Gastroenterology, the median follow-up was 53 months.

At eight years, the rate of hepatitis B surface antigen seronegativity was 88%, and 98% of patients had undetectable hepatitis B virus (HBV) DNA. The virologic relapse rate was 5% at one year, 10% at three years, 13% at five years, and 16% at eight years.

In particular, the three-year virological relapse rate with lamivudine was 17%. There was no relapse with entecavir and a 7% relapse with the antiviral combination. The overall eight-year survival rate was 83%, with no difference between treatment groups.

Of the 42 patients who relapsed, 31 in the lamivudine group and five in the combination group had the YMDD mutation. However, there was only one patient with transient virological rebound in the entecavir group, with no evidence of resistant mutation. The authors say this shows the value of newer antiviral agents with high barriers to resistance.

Given the increased risk of HBV rebound with lamivudine monotherapy, the researchers note that at their institution these monotherapy patients with hepatitis B surface antigen seropositivity will also be given adefovir even when they have undetectable HBV DNA.

The researchers conclude that outcomes are excellent without HBIG. For patients with pre-existing drug-resistant mutations, they recommend using an antiviral with a high barrier to resistance. For those who do have pre-existing drug-resistant mutations, they advise combination therapy.

SOURCE: http://bit.ly/17KcqyV

Am J Gastroenterol 2013.