Merck reports positive phase 2 results for HIV drug, shows additional insights Print E-mail
By Deborah Sterescu -   
Monday, 18 July 2011 14:43
Merck (NYSE:MRK) said Monday that phase two study results of its Isentress tablets, as a combination therapy for HIV-positive patients, showing similar efficacy to another anti-retroviral med, with fewer reported drug-related adverse events.

The double-blind, randomized trial, which extended out to 240 weeks, evaluated Isentress in previously untreated HIV-1 type infected patients, in comparison with efavirenz, each in combination with tenofovir/lamivudine.

The results showed that Isentress, when taken orally twice daily, showed efficacy similar to the regimen containing efavirenz, suppressing HIV viral load to undetectable levels and improving CD4 cell counts, or the number of immune T cells expressing the glycoprotein CD4.

At week 240, the regimen using Isentress suppressed HIV-1 viral load levels to below 50 copies/mL in 68.8% of patients, versus 63.2% of patients in the efavirenz arm. CD4 cell counts were also higher in the Isentress regimen, Merck said.

In addition, data showed that the drug resulted in fewer reported drug-related adverse events than efavirenz, and showed a modest impact on low-density lipoprotein (LDL) cholesterol, or the bad form of cholesterol, and triglycerides.

"Because physicians consider many factors when selecting antiretroviral therapy for adult HIV-1 patients new to treatment, the results seen in this Phase II study with ISENTRESS in combination therapy showing a modest impact on LDL and triglycerides provide important insights," said the primary investigator of the study, Dr. Eduardo Gotuzzo.

Isentress works to limit the ability of the virus to replicate and infect new cells, slowing the progression of the disease. The drug is now approved in more than 45 countries for use in treatment-naive adult HIV patients, and in more than 90 countries for use in treatment-experienced adult patients with the disease.


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