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Assistant Professor, Clinical Pharmacy Practice, Arnold and Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY; Department of Pharmacy, St. Luke's Hospital, 1111 Amsterdam Ave., New York, NY 10025-1716, fax 212/523-5703, arivkina{at}liu.edu
Reprints: Anastasia M Rivkin PharmD BCPS
OBJECTIVE: To evaluate properties of the new acyclic nucleotide analog adefovir dipivoxil in the treatment of chronic hepatitis B (CHB).
DATA SOURCES: MEDLINE and PubMed searches from 1966 to December 2003 were performed with the headings chronic hepatitis B, interferon alfa-2b, lamivudine, liver transplant, and adefovir dipivoxil.
STUDY SELECTION AND DATA EXTRACTION: Randomized controlled studies and meta-analyses were evaluated in detail. A manual search was performed using references from retrieved primary literature, review articles, editorials, postgraduate course syllabi from national meetings, and textbooks. Emphasis was placed on controlled, prospective, randomized trials. National meeting abstract presentations were included if the information offered was original.
DATA SYNTHESIS: CHB is a major viral infection with an estimated 400 million carriers worldwide. Medications available to treat CHB include interferon alfa-2b and lamivudine, both agents having significant limitations. Adefovir dipivoxil is a novel nucleotide analog which, when given at 10 mg/day for 48 weeks, improved liver histology in 28% more patients with hepatitis B e antigen (HBeAg)-positive CHB, and in 31% more patients with HBeAg-negative CHB compared with placebo (p < 0.001). Additionally, adefovir dipivoxil therapy significantly improved virologic and biochemical parameters in both HBeAg-positive and -negative CHB patients. Adefovir dipivoxil offers important advantages over other CHB treatment options: it maintains activity against lamivudine-resistant CHB, has good efficacy against HBeAg-negative CHB, and has minimal adverse effects at the 10-mg/day Food and Drug Administration–approved dose.
CONCLUSIONS: Approved medications for the treatment of CHB have many limitations, and adefovir dipivoxil provides a new important option as an initial treatment, as well as treatment in lamivudine-resistant patients.
Key Words: adefovir dipivoxil, chronic hepatitis B, nucleotide analog
Published Online, February 27, 2004. www.theannals.com, DOI 10.1345/aph.1D362
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-04-013-H01
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