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Gilead’s HIV Inhibitor Meets Phase II Endpoint

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Gilead Sciences, Inc. completed a Phase II trial of GS 9137, a novel oral HIV integrase inhibitor. The study met its primary endpoint of non-inferiority in viral load reduction in HIV-positive patients receiving 50 mg or 125 mg of GS 9137 once daily with 100 mg of ritonavir, in combination with an antiretroviral regimen compared to a comparator protease inhibitor regimen.

This ongoing study is a partially-blinded, randomized, active-controlled, 48-week trial to evaluate the non-inferiority of once-daily GS 9137 versus boosted comparator protease inhibitors in highly treatment-experienced HIV-infected patients. The primary endpoint of the study was DAVG24, a measure of viral load reduction over 24 weeks.

Integrase inhibitors are antiretrovirals that interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Novel classes of HIV-fighting drugs are needed as patients live longer and exhaust currently available treatment options.

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