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Merck To Stop Late-Stage Study Of HIV Treatment

From Associated Press (November 29, 2010)

WHITEHOUSE STATION, N.J. -- Drug maker Merck & Co. said Monday it will end a late-stage study of a once-daily version of Isentress tablets after it found that version of the HIV treatment did not do as well as a twice-daily version already approved by the Food and Drug Administration.

The Whitehouse Station, N.J., company said the study evaluated an 800-milligram version of the drug designed to be taken once a day compared to a 400-milligram dose taken twice daily in patients who are starting treatment for the first time.

Isentress is administered in combination with other drugs and also is approved for patients who have already started treatment.

A total of 83.2 percent of patients receiving the once-daily regimen achieved undetectable viral levels after 48 weeks compared to 88.9 percent of patients receiving the twice-daily regimen.

Merck said it is recommending that patients enrolled in the once-daily dosing regimen for the study switch to taking the FDA-approved, twice-daily dose.

Isentress is approved in more than 90 countries. The drug inhibits the insertion of HIV DNA into human DNA by the integrase enzyme, which limits the virus’s ability to replicate and infect new cells.

Merck shares fell 47 cents to $34.32 in Monday morning trading.


Posted: November 2010