Virological, Immunological, and Lipid Markers Maintained With Dual-Boosted Protease Inhibitor Therapy:
Presented at AIDS 2006, Toronto – Dr Dick QuanSYDNEY

TORONTO, CANADA -- August 18, 2006 -- Dual boosting of protease inhibitors (PIs) results in bioequivalent profiles, a result that spares therapeutic options if PI-only regimens fail, researchers reported here at the 16th International AIDS Conference (AIDS 2006).

"We are trying to see what happens to patients who are put on a dual protease inhibitor without a nucleoside backbone," explained study investigator Dick Quan, MD, treating physician, Holdsworth House Medical Practice, Sydney, Australia, which specializes in treating patients with HIV. "The study demonstrates that pharmacokinetically, whether you take PIs once or twice a day, they were equivalent."

The open-label, crossover prospective study looked at 12 male patients who were on antiretroviral therapy. They had plasma HIV RNA levels of <50 copies/mL and CD4 T lymphocyte counts of 568/mcL. The first phase of the study involved administration of lopinavir/ritonavir (400 mg/100 mg) once daily and atazanavir (150 mg) twice daily.

Researchers measured fasting lipids, immunological and virological markers, and chemistry on day 15 of the study. Subjects ate a meal and were administered medication after which their plasma concentrations were measured at 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing. In the second phase of the study, the dosing was altered to once daily at a dose of 800 mg of lopinavir and 200 mg of ritonavir as well as a once daily dose of atazanavir 300 mg.

A second pharmacokinetic assessment was conducted on day 29 of the study, which included a 24-hour sample.

Results show that virologic, immunologic, and lipid markers were maintained throughout the evaluation period.

Dr. Quan noted that the study's small number of patients and short duration limit the robustness of the results. However, the PIs' bioequivalent profiles indicate wider therapy choices and will delay the chance of resistance. With once-daily dosing, adherence will likely be enhanced, he added.

"We need further investigation on this combination, but it may let people save their nucleoside backbone for if they fail the PI regimen," said Dr. Quan. "The idea is to preserve therapeutic options for patients.

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