WHITEHOUSE STATION (dpa-AFX) - Healthcare giant Merck & Co. Inc. (MRK), Monday said the US FDA approved new labeling for Isentress (raltegravir) tablets, Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination HIV therapy.
The updated prescribing information now includes 240-week results from the STARTMRK study, the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adult patients with HIV-1 infection.
The results show that the regimen containing ISENTRESS in combination therapy demonstrated long-term viral suppression and a greater immunologic response than the efavirenz-containing regimen, as well as a proven, long-term safety and tolerability profile through 240 weeks in previously untreated (treatment-naïve) adult HIV-1 infected patients.
ISENTRESS is an integrase inhibitor indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS.
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