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Reuters Health Information (2004-01-06): Hepsera reduces lamivudine-resistant HBV levels in liver transplant patients


Hepsera reduces lamivudine-resistant HBV levels in liver transplant patients

Last Updated: 2004-01-06 10:52:47 -0400 (Reuters Health)

NEW YORK (Reuters Health) - 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.

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