December 21, 2007

Isentress Wins Approval in European Union

The HIV integrase inhibitor Isentress (raltegravir) was approved in the European Union today for use in combination with other antiretrovirals for treatment-experienced patients who have detectable viral loads despite ongoing antiretroviral therapy.

The approval of Isentress, developed and manufactured by Merck & Co., allows for access to the drug in the 27 European Union countries, as well as Norway and Iceland. It was approved earlier this year in the United States, Canada and Mexico.

Isentress is a promising HIV drug for treatment-experienced patients with drug-resistant virus because it works differently than other available antiretrovirals. After HIV’s genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. A viral enzyme called integrase then helps to hide HIV’s DNA inside the cell’s DNA. Once this happens, the cell can begin producing genetic material for new viruses. Integrase inhibitors, such as Isentress, are designed to block the activity of the integrase enzyme and to prevent HIV DNA from meshing with healthy cell DNA.

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Previous Comments:

Chris, San Francisco, 2007-12-29 23:02:56
Hey Ken from Lauderhil, or anyone else taking Isentress, what's your experience with side effects on this med? Any lipo side effects or others you've experience so far?

peter abbott, san francisco, 2007-12-28 02:26:16
News about approval in the EU is interesting for me because I have coverage in Austria and have found in the past that Austria does its own approval process and sadly if they choose to "save" money, they don't even consider the approval process. So thus it is not approved. Expensive meds are thus kept out of the country or on self-pay.

Ken, Lauderhill FL, 2007-12-27 17:39:20
I started on Isentress the beginning of Oct 07 and in 30days of being on the med my viral load when undecided for the first time in 16yrs

Richard Dow, Nyack, NY 10960, 2007-12-26 13:42:31
Is Isentress approved for use in USA? In process? Or how soon might it be approved? Thanks R.