Experimental Apricitabine Demonstrates Promising Safety at 24 Weeks: Presented at AIDS 2008

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Title: Experimental Apricitabine Demonstrates Promising Safety at 24 Weeks: Presented at AIDS 2008
URL: http://www.pslgroup.com/dg/22768E.htm
Doctor's Guide
August 7, 2008

By Ed Susman

MEXICO CITY -- August 6, 2008 – Apricitabine, an investigative nucleoside reverse transcriptase inhibitor presently aimed as a second-line treatment against resistant human immunodeficiency virus (HIV), exhibited a low propensity for mitochondrial, hepatic, and bone-marrow toxicity in 24-week safety data, according to researchers presenting here at the 17th International AIDS Conference (AIDS 2008).

"Apricitabine showed promising activity and safety in both treatment-naïve and treatment-experienced HIV infected patients," said Susan Cox, PhD, Avexa Limited, Victoria, Australia, speaking here on August 5 at an oral poster presentation.

"There was no evidence of peripheral neuropathy, myelotoxicity, hepatotoxicity, hyperlactaemia, lipidaemia, hyperlipasaemia, pancreatitis, rash, hypersensitivity, or renal toxicity from apricitabine therapy," Dr. Cox added.

Her study compared 2 doses of apricitabine with lamivudine. Patients were assigned as follows: 17 highly treatment-experienced patients with HIV infection received the 600-mg dose of apricitabine; 18 patients received the 800-mg dose of apricitabine; and 16 patients received lamivudine.

Dr. Cox noted that none of the subjects treated with apricitabine reported any serious adverse events. Three lamivudine patients had serious adverse events. The number of patients who reported either none or 1 adverse drug effect was similar across all 3 groups: 11 in the 600-mg apricitabine group, 17 in the 800-mg apricitabine group, and all 16 of the lamivudine patients.

Five patients on apricitabine reported 8 adverse side effects that might have been caused by treatment. One patient in the 600-mg group reported mild diarrhoea and mild dizziness; another experienced mild nausea requiring a temporary interruption in the study drug. In the 800-mg dose group, 1 patient reported mild pyrosis; another reported mild anorexia and mild weight loss; and another reported mild gastric intolerance at week 4 and moderate diarrhoea at week 12. No one in any of the study groups discontinued treatment due to adverse side effects.

About 30% of the patients in each group were women; the average age was 38 years. About half the patients in each group had 3 or more thymidine analogue-associated mutations, which confer resistance to several members of nucleoside analogue class and therefore limit options for treatment.

"This is a very promising drug," concluded Pedro Cahn, MD, Huesped Foundation, Buenos Aires, Argentina, and President of the International AIDS Society. "It seems like it is a pretty clean drug as far as side effects are concerned."

Dr. Cahn noted that the ability of apricitabine to overcome viral strains resistant to other nucleoside analogues -- the backbone of combination antiretroviral therapy -- could make the drug useful if its efficacy and safety are borne out in phase 3 studies.

Funding for this study was provided by Avexa Limited.

[Presentation title: Safety Profile of Apricitabine, A Novel NRTI, During 24-Week Dosing in Experienced HIV-1 Infected Patients. Abstract TUAB0106]

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