First-Line Protease Inhibitor Shows Benign Impact on Lipids, Diabetes in Patients With HIV: Presented at AIDS 2010
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First-Line Protease Inhibitor Shows Benign Impact on Lipids, Diabetes in Patients With HIV: Presented at AIDS 2010

By Ed Susman

VIENNA -- July 23, 2010 -- In patients with HIV, use of boosted darunavir and atazanavir appear to have little negative impact on plasma lipids and or diabetes parameters, researchers said here at the 18th International AIDS Conference.

In the 12-week analyses, none of the patient groups experienced lipid levels that exceeded National Cholesterol Education Program guidelines, said Judith Aberg, MD, Bellevue Hospital Center at New York University, New York, New York, during her poster presentation on July 21.

Dr. Aberg said that patients treated with a combination therapy that includes darunavir boosted with ritonavir had modest increased in triglycerides from a mean baseline figure of 114 to 137 mg/dL. The National Cholesterol Education Program goal for triglycerides is 150 mg/dL.

She also reported that patients treated with a combination therapy containing atazanavir boosted with ritonavir experienced a mean rise in triglycerides from 114 to 127 mg/dL.

"Both of these therapies are preferred treatment for patients with HIV and we saw no meaningful differences between them as it concerned impact on lipids, diabetes, or kidney function," she said.

She also reported the following:
· Patients treated with darunavir experienced a mean rise in total cholesterol from 142 to 162 mg/dL, below the guideline goal of 200 mg/dL.
· Patients treated with atazanavir experienced a mean rise in total cholesterol from 165 to 170 mg/dL.
· Patients treated with darunavir had a mean rise in low-density lipoprotein cholesterol from 85 to 98 mg/dL, below the guideline figure of 130 mg/dL.
· Patients treated with atazanavir experienced a mean rise in low-density lipoprotein cholesterol from 100 to 116 mg/dL.

The differences in changes between the medications did not achieve statistical significance, Dr. Aberg said.

"We saw no clinically relevant changes in fasting glucose, fasting insulin, insulin sensitivity, or creatinine clearance with darunavir/ritonavir therapy or atazanavir/ritonavir therapy from baseline to week 12," she said.

Dr. Aberg said the study would continue to collect data over a 48-week period.

Researchers enrolled 65 treatment-naïve patients adults with HIV with viral loads of at least 1,000 copies/mL. The researchers reported that 32 of 34 patients on darunavir completed the first 12 weeks of the trial while 30 of 31 patients assigned to receive atazanavir in the open-label trial finished the first 3 months of treatment.

Participants had to be free of lipid-lowering medicating for at least 1 month prior to starting the study. Statin therapy was available if needed after 12 weeks of antiretroviral therapy.

[Presentation title: METABOLIK (Metabolic Evaluation in Treatment-Naïves
Assessing the Impact of Two Boosted Protease Inhibitors on Lipids and Other Markers):
Comparison of the Metabolic Effects of Darunavir/Ritonavir Versus Atazanavir/Ritonavir Over 12 Weeks. Abstract WEPE0111]


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