vicriviroc

Gathe reported that 64% of the 486 patients who received vicriviroc and 62 percent of the

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The Merck presentation is on the drug, vicriviroc, an experimental HIV salvage treatment.

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In the two phase III studies, patients who had previous treatments with antiretroviral medicines were assigned to receive vicriviroc plus optimized background therapy or just optimized background therapy alone.

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Merck said that an ongoing, fully enrolled phase II clinical study of vicriviroc in treatment-naive HIV patients will continue unchanged.

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He said that there were hints that vicriviroc could boost results over background therapy alone if there were two or less active drugs on board.

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The company announced that it will not file a New Drug Application for vicriviroc, a CCR5 cell entry inhibitor with a checkered clinical history, following presentation of pooled studies at the Conference on Retroviruses and Opportunistic Infections here.

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In the studies cited, HIV-infected patients whose virus was not well controlled were assigned to receive vicriviroc 30 mg once daily or placebo in combination with an optimized background regimen -- a regimen required to have at least two fully active antiretroviral drugs including a ritonavir-boosted protease inhibitor.

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Treatment-experienced patients from the vicriviroc clinical trials who are benefiting from vicriviroc treatment will continue to have access to the medicine as provided for in the trial protocols.

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Joseph Gathe, MD, president of Therapeutic Concepts, Houston, who presented the results to a packed house during an oral abstract session here, said, "Optimized background therapy in these trials included more potent antiretroviral drugs than in the vicriviroc phase II clinical trials or in phase III trials of recently approved HIV drugs."

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SAN FRANCISCO -- The failure of the investigational antiretroviral drug vicriviroc to distinguish itself in a phase III clinical trial has derailed plans by Merck to seek Food and Drug Administration approval for the agent in treatment-experienced patients.

MedPageToday.com - medical news plus CME for physicians 2010