Adefovir Rapidly Suppresses HBV in HBeAg-negative Patients Who Develop Resistance to Lamivudine

Progression of hepatitis B in patients with lamivudine (Epivir-HBV)-resistant strains is slowed down by adefovir dipivoxil/ ADV (Hepsera). Whether the time point of ADV administration (genotypic vs. phenotypic resistance) influences the outcome of therapy is unknown.

In the current study, Italian researchers compared the outcome of ADV therapy in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B patients with genotypic and phenotypic resistance to lamivudine.

Results

Ten milligrams of ADV was administered daily for 2 years to 46 HBeAg-negative patients at the time of phenotypic resistance (group A, >6 log(10) copies/mL of hepatitis B virus [HBV] DNA and high alanine aminotransferase [ALT] levels) and 28 patients at the time of genotypic resistance (group B, 3-6 log(10) copies/mL of HBV-DNA and normal ALT).

HBV DNA was assessed every 2 months using Versant 3.0 assay, and lamivudine resistance was confirmed via INNO-LiPA assay in all patients.

By month 3, HBV DNA tested negative in all patients from group B compared with only 20 (46%) in group A (P < .0001).

  The 2-year rates of virological response were 100% in the former patients and 78% in the latter ones (P < .0001).

ALT levels remained persistently normal in all group B patients, whereas in group A patients, they normalized at rates of 50% at month 6 (P < .0001), 72% at month 12 (P < .01), and 93% at month 24.

None of the patients developed ADV resistance or ADV-related side effects.

In conclusion, the authors write, “To optimize antiviral treatment in HBeAg-negative patients selecting resistant strains to lamivudine, ADV should be added to lamivudine as soon as genotypic resistance is detected.”

Department of Gastroenterology and Endocrinology, AM and A Migliavacca Center for Liver Disease, IRCCS Maggiore Hospital, Fondazione Policlinico, Mangiagalli e Regina Elena, University of Milan, Italy.

12/16/05

Reference
P Lampertico and others. Adefovir rapidly suppresses hepatitis B in HBeAg-negative patients developing genotypic resistance to lamivudine. Hepatology 42(6): 1414-1419. December 2005.

 










FDA-approved Treatments for HBV

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