Adefovir And Lamivudine Combo Is Effective In Lamivudine-Resistant Hepatitis B Patients

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Apr 2007 - 1:00 PDT

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Long-term treatment with adefovir dipivoxil (ADV, HepseraR) and lamivudine provides multiple benefits in lamivudine-resistant patients with chronic hepatitis B, researchers announced at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).

The results, reported by an Italian group, showed that the combination decreased the risk of genotypic resistance to adefovir and prevented both virological rebound and clinical resistance for up to three years.

Long-term therapy with lamivudine is initially effective but genotypic hepatitis B resistance develops in about 25% of patients at one year and in 71% by four years, principal investigator Professor Pietro Lampertico, who is an assistant professor of gastroenterology at the University of Milan, said.

Add-on ADV therapy has been established as an effective treatment strategy for patients developing lamivudine resistance but the long-term risk of genotypic resistance to ADV and the impact of ADV combined with lamivudine on the progression of cirrhosis has not been known, he added.

In the trial, 145 patients received 10 mg/d of adefovir as add-on therapy to ongoing lamivudine treatment.

HBV DNA was assessed every two months, and drug resistance was assessed annually in viremic patients.

Most patients achieved a virological and biochemical response (80% and 84%) for up to three years. None developed a virological or clinical breakthrough regardless of the degree of viral suppression.

No patient developed genotypic resistance for rtA181V and rtN236T. Three patients developed the rtA1811T mutation as a mixed viral population with rtA181A while responding to therapy.

Combination therapy prevented clinical decompensation in all cirrhotic patients.

Professor Lampertico concluded that the data demonstrate that the adefovir-lamivudine combination is an effective and safe treatment strategy for lamivudine-resistant patients for at least three years.

Approximately one million individuals are infected with the hepatitis B virus in Europe every year. Of these, roughly 90,000 become chronically infected carriers.

The study was sponsored by Gilead.
www.gilead.com

Written by: Jill Stein
Jill Stein is a Paris-based freelance medical writer.

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