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Merck ends HIV drug study

Merck is to end its study investigating once-daily Isentress for patients with HIV-1 after it failed to improve on a twice-daily version

Merck is to end its study investigating once-daily Isentress (raltegravir) for patients with HIV-1 after the drug failed to improve on an already approved twice-daily version in a phase III trial.

The trial evaluated the safety and efficacy of an investigational once-daily 800mg dose of the drug against the approved twice-daily 400mg dose, each in combination with a once-daily dose of emtricitabine and tenofovir disoproxil fumarate, in adult treatment-naïve HIV-1-infected patients.

Of the patients taking the once-daily does, 83.2 per cent achieved undetectable viral levels, compared to 88.9 per cent of patients in the twice-daily group. This difference, however, did not meet the pre-defined statistical criteria for non-inferiority.

Drug safety was found to be similar in both regimens, and consistent with current labelling for Isentress.

The 400mg version of the drug is currently the only approved integrase inhibitor for the treatment of HIV-1. It works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme.

Merck said it is notifying clinical investigators of the decision to cancel the trial this week, with a recommendation that patients enrolled in the once-daily dosing arm of the study be switched to Isentress twice daily.

30th November 2010

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