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A new oral nucleoside reverse transcriptase inhibitor, adefovir dipivoxil, is found to be well-tolerated and shows moderate anti-HIV activity, according to Dr. Steven G. Deeks of San Francisco General Hospital and colleagues.
Adefovir dipivoxil is a novel nucleotide analogue with several promising in vitro anti-human immunodeficiency virus (HIV) characteristics. Dr. Deeks' group evaluated the safety and efficacy of monotherapy with adefovir dipivoxil in 72 patients with moderately advanced HIV infection. Subjects were randomly assigned in a 2:1 ratio to receive adefovir dipivoxil or placebo as a once-daily oral dose for 6 weeks, followed by 6 weeks of open-label adefovir dipivoxil. They evaluated two doses of adefovir dipivoxil—125 mg and 250 mg.
Adefovir dipivoxil was safe and well-tolerated after a 12-week course of treatment, they report. By week 6, changes in absolute CD4 T cell levels and HIV-1 RNA levels were significantly greater with adefovir dipivoxil than with placebo, and these changes were maintained at 12 weeks.
In addition, Dr. Deeks' group detected genotypic changes from baseline in only 1 of the 24 subjects who received 125 mg of adefovir dipivoxil. They believe that the preliminary data indicate that high-level drug resistance to adefovir dipivoxil may not be a factor limiting the long-term use of this drug. Larger studies to characterize the clinical benefits of adefovir dipivoxil as therapy in HIV disease are currently underway.
Meanwhile, Gilead Sciences, Inc., announced an expanded access program for adefovir dipivoxil (Preveon). The company plans to make the drug available to patients in the US with advanced HIV infection as an antiretroviral therapy and prophylaxis for cytomegalovirus disease.
"Currently there is a great need for additional HIV treatments that are convenient to take and can be readily combined with other antiretroviral drugs," Dr. James Rooney of Gilead said. "In making Preveon available through expanded access, patients with few alternatives will have another option to add to combination regimens."
For more information on the expanded access program, physicians can call 800-GILEAD-5.
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