Gilead's GS 9137 decreases viral load during phase 1/2 HIV study

By Angela McDaniels

Seattle, Feb. 9 - Gilead Sciences Inc. said that HIV patients treated with GS 9137, a novel oral HIV integrase inhibitor, experienced significant reductions in viral load during a phase 1/2 dose-escalation study.

The double-blind, randomized, placebo-controlled monotherapy study was designed to evaluate the safety, tolerability and antiviral activity of GS 9137 in HIV-infected treatment-naive and treatment-experienced patients.

Forty patients were randomized to receive one of five doses of GS 9137 or a placebo with food for 10 days. The study evaluated GS 9137 at 200 mg twice daily, 400 mg twice daily, 800 mg twice daily, 800 mg once daily and 50 mg boosted with 100 mg of ritonavir QD.

At study entry, patients were not receiving antiretroviral therapy. Gilead said the average viral load was 47,500 copies per mL and the mean CD4 cell count was 442 cells per mL. The primary efficacy endpoint was the maximum reduction in viral load from baseline.

The median decrease in viral load was between 9,600 and 20,300 copies, depending on the dose, compared to a decrease of 2,400 copies for a placebo, the company said.

The data was presented this week at the 13th Conference on Retroviruses and Opportunistic Infections in Denver.

GS 9137, also known as JTK-303, was licensed to Gilead by Japan Tobacco in March 2005. Under the terms of the agreement, Gilead has exclusive rights to develop and commercialize GS 9137 in all countries of the world excluding Japan.

Gilead Sciences is a biopharmaceutical company based in Foster City, Calif.

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