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Lamivudine-Resistant Hepatitis B Patients Achieve Sustained Benefits With Adefovir Add-On Therapy: Presented at EASL

By Jill Stein

BARCELONA, SPAIN -- April 17, 2007 -- Long-term treatment with adefovir dipivoxil and lamivudine decreases the risk of genotypical resistance to adefovir in lamivudine-resistant hepatitis B patients for up to three years, according to data presented here at the 42^nd Annual Meeting of the European Association for the Study of the Liver (EASL).

In addition, combination therapy with adefovir and lamivudine prevented virological rebound and clinical resistance throughout the treatment period.

Pietro Lampertico, MD, assistant professor, division of gastroenterology, University of Milan, presented results in 145 patients who received 10 mg daily of adefovir as add-on therapy to ongoing lamivudine 100 mg daily.

"While add-on adefovir is an effective treatment for patients who develop lamivudine resistance, the long-term risk of genotypic resistance to adefovir and the impact of the adefovir plus lamivudine combination on the progression of cirrhosis is not known," Dr. Lampertico stated in his presentation on April 13^th.

Eighty-three percent of subjects were negative to hepatitis B e antigen (HBeAg) and 73% had cirrhosis.

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

At a mean follow-up of 40 months, 80% of patients had achieved a virological response and 84% had a biochemical response. 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. These are genetic mutations that have been associated with adefovir resistance.

While none of the cirrhotic patients developed clinical decompensation, 12% developed hepatocellular carcinoma.

A few patients (7%) had a greater than 0.5 mg/dl increase in serum creatinine.

"Because of its safety, durable efficacy, and delayed resistance, adefovir should be considered a primary therapeutic option for the treatment of lamivudine-resistant hepatitis B patients," Dr. Lampertico said.

He also recommended that adefovir be added to lamivudine as soon as virological rebound is detected.

Hepatitis B is one of the top ten causes of death worldwide. as many as 1.2 million people worldwide die each year from complications of the virus. HBeAg-negative hepatitis, which accounts for roughly 14% to 33 % of chronic hepatitis B, typically requires prolonged drug therapy.


[Presentation title: 3 Years of Adefovir and Lamivudine Combination Therapy Minimizes the Risk of Genotypic Resistance to adefovir in Lamivudine-Resistant Patients. Abstract Number 57]

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