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KATARINA писал(а): ISENTRESS

Isentress is an integrase inhibitor manufactured by Merck & Company. It was approved by the U.S. Food and Drug Administration (FDA) in October 2007. Isentress is approved for treatment-experienced patients who have HIV strains that are resistant to multiple antiretroviral drugs. It is not yet approved for people with drug-sensitive HIV strains, such as those starting antiretroviral therapy for the first time.

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.

Isentress must be used in combination with other anti-HIV drugs.

What is already known about Isentress?
The Isentress dose is one 400mg tablet taken by mouth twice a day. It can be taken with or without food.

Isentress holds promise for HIV-positive patients who no longer respond to other HIV drugs. Because Isentress targets HIV differently than all other available antiretrovirals, chances are that many people living with the virus—regardless of which drugs have failed them in the past—will likely benefit from using Isentress. Two large large Phase III clinical trials have determined that Isentress, when combined with other drugs, is effective for patients whose virus has adapted to other HIV drugs used in the past. However, Isentress worked best when it was combined with at least two other drugs that the virus was sensitive to. For this reason, it is best to use drug-resistance testing to determine which drugs your virus is sensitive to; the results will show which antiretrovirals are best to combine with Isentress.

Isentress is not yet approved for people with HIV that have no, or limited, resistance to other available antiretroviral drugs. This includes HIV-positive people beginning treatment for the first time. However, preliminary data from a study evaluating the drug in patients new to HIV treatment suggest that Isentress is comparable to standard-of-care Sustiva (efavirenz), at least for 24 weeks of treatment. The FDA has not yet reviewed these data.

The side effects most commonly reported among study volunteers who received Isentress were diarrhea, nausea, and headache.