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Home Industry News MSD shows Isentress to maintain reductions in HIV-1 viral load

MSD shows Isentress to maintain reductions in HIV-1 viral load

7th February 2008

Merck, Sharp and Dohme (MSD) has reported results of two phase III studies showing that its Isentress tablets (raltegravir), in combination with other anti-HIV medicines, maintain significant HIV-1 viral load suppression in treatment-experienced adults.

The studies also demonstrated that Isentress increased CD4 cell counts through the 48 weeks of therapy.

Over the two trials, 699 treatment-experienced patients were enrolled with all subjects failing antiretroviral therapies.

Late last year, the US Food and Drug Administration granted Isentress accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adults.

The study was based on the demonstrated viral load reductions and CD4 cell count increases analysed through 24 weeks in the two phase III studies.

However, it was this week that the full 48-week data was first present at the 15th Conference on Retroviruses and Opportunistic Infections.

Commenting on the study, lead investigator Roy Steigbigel stated: “The 48-week efficacy results are consistent with what we observed at week 24.”

Earlier this month, MSD and Schering-Plough reported the results of its Enhance trial which compared the effects of ezetimbe and high-dose simvastatin against simvastatin alone on the atherosclerotic process in patients with heterozygous familial hypercholesterolemia.

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