By Ed Susman
SYDNEY, AUSTRALIA -- July 25, 2007 -- Total cholesterol and low-density lipoprotein cholesterol significantly increase among HIV patients taking an efavirenz (Sustiva)-based regimen when compared with patients taking a regimen anchored by the investigative rilpivirine (TMC278), researchers said here at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.
Rilpivirine is a new drug in the non-nucleoside reverse transcriptase inhibitor class of antiretroviral agents.
"TMC278 resulted in minimal changes in lipid profiles after 1 year of treatment and may have a potential benefit versus efavirenz," said Kiat Ruxrungtham, MD, Professor of Medicine, Chulalongkorn University, Bangkok, Thailand.
In his oral presentation on July 24th, Dr. Ruxrungtham described the study that examined three different doses of rilpivirine and efavirenz and their metabolic responses in HIV-infected patients over the course of a year.
"There was a clear increase from baseline in total cholesterol for the efavirenz group of patients but a minimal increase for the TMC278 dose groups," he said.
He illustrated that the increase for rilpivirine was about 5 mg, but the increase in cholesterol for efavirenz after 48 weeks was about 31 mg, a difference that reached statistical significance at the P <.001 level.
Similarly, he found a 1-mg increase in low-density lipoprotein cholesterol among the rilpivirine patients, but a 15-mg increase with efavirenz (P <.001).
There was a 5-mg increase in high-density lipoprotein (HDL) cholesterol with rilpivirine and a 12-mg increase with efavirenz (P <.001).
Dr. Ruxrungtham found no significant difference between the two treatments in total cholesterol/HDL cholesterol ratio.
"Mean changes from baseline in glucose levels and insulin sensitivity were minimal and not clinically relevant for both groups," he said.
Katia Boven, MD, Director, Global Clinical Development, Tibotec, Inc., Yardley, Pennsylvania, said that the company, part of Johnson & Johnson, will begin phase 3 clinical trials later this year using rilpivirine in combination with either Truvada (emtricitabine and tenofovir) or Kivexa (abacavir and lamivudine) compared with efavirenz and the same backbone.
[Presentation title: The Metabolic Profile of TMC278, an Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). Abstract TUAB105]
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