Hepsera Reduces 3T-Resistant HBV Levels in LTP

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Hepsera Reduces Lamivudine-Resistant HBV Levels in Liver Transplant PatientsNEW YORK (Reuters Health) Jan 06 - Treatment with adefovir dipivoxil
(Hepsera, Gilead Sciences) both prior to and following liver transplantation
in patients with lamivudine-resistant chronic hepatitis B (HBV) infection,
significantly improves virologic, biochemical and clinical parameters,
results of an open-label, compassionate use study indicate.

"Adefovir dipivoxil meets an urgent, unmet medical need and presents a
potential life-saving treatment option for pre- and post-liver transplant
patients with lamivudine-resistant HBV who are at high risk for morbidity
and mortality," the Adefovir Dipivoxil Study 435 International Investigators
maintain in their report, published in the December issue of Hepatology.

Treatment with hepatitis B immune globulin and nucleoside analogs such as
lamivudine ameliorate HBV recurrence, Dr. Eugene R. Schiff, at the
University of Miami in Florida, and colleagues explain. But because emerging
lamivudine resistance can lead to rapid disease progression, they examined
the role of adefovir, a nucleotide analog of adenosine monophosphate, for
patients with lamivudine-resistant HBV.

Included were 128 patients enrolled prior to undergoing liver transplant and
196 post-liver transplantation, who were treated with Hepsera 10 mg/day.
Child-Pugh-Turcotte (CPT) scores improved in more than 90% of subjects in
both groups. These improvements were accompanied by improvements in ALT,
albumin, bilirubin and prothrombin time.

HBV DNA levels declined by 4.1 to 4.3 log-10 copies/mL over 48 weeks of
treatment.

The authors report that treatment-related adverse events tended to be mild
to moderate in severity, and that "the safety profile was consistent with
the advanced stage of liver disease and the attendant comorbidities."

There appeared to be no adefovir resistance mutations after 48 weeks of
therapy.

Survival at 1 year was 84% for pre-transplant patients and 93% for
post-transplant patients, leading Dr. Schiff and his colleagues to conclude
that adefovir dipivoxil provides a clinically meaningful benefit.

In a related editorial, Dr. Fabien Zoulim recommends that adefovir dipivoxil
be started soon after lamivudine resistance emerges.

Dr. Zoulim, at INSERM in Lyon, France, also believes that adefovir and
lamivudine should be used in combination to prevent the selection of
multiple drug-resistant strains.

Hepatology 2003;38:1353-1355,1419-1427.

Reuters Health Information 2004. © 2004 Reuters Ltd.
http://www.medscape.com/viewarticle/466770