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| Isentress Gets FDA Approval |
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© 2007 Abesha Care Inc. All Right Reserved. office@abeshacare.org
October 12, 2007
The U.S. Food and Drug Administration (FDA) has
granted approval to Merck’s Isentress (raltegravir),
the first of a new class of HIV drugs known as
integrase inhibitors. Isentress, at a dose of one
400 mg tablet twice a day, has been approved
specifically for use in combination with other
antiretrovirals (ARVs) to treat treatment-
experienced HIV-positive patients with resistance to
multiple ARVs
The approval of Isentress is based on data from
two clinical trials involving 699 highly treatment
experienced HIV-positive adults. Isentress, when
combined with other approved ARVs, reduced viral
loads to undetectable in up to 62 percent of the
patients who received the drug, compared to 36
percent of those who received a placebo plus other
HIV drugs.
The side effects most commonly reported among
study volunteers who received Isentress were
diarrhea, nausea, and headache. Blood tests
showed abnormally elevated levels of a muscle
enzyme—creatine kinase—in some patients
receiving Isentress. According to the FDA,
Isentress should be used with caution by patients
who are at increased risk for muscle problems like
myopathy and rhabdomyolysis, which includes
patients using other medications known to cause
these conditions.
Isentress works by blocking HIV’s integrase
enzyme. After HIV's genetic material is deposited
inside a cell, its RNA must be converted (reverse
transcribed) into DNA. The integrase enzyme helps
to hide HIV's DNA inside the cell's DNA. Integrase
inhibitors stop this process and prevent HIV DNA
from meshing with healthy cell DNA.
While preliminary clinical trial results suggest that
Isentress is comparable to Sustiva (efavirenz)
among first-time treatment takers, it has not yet
been approved for this HIV-positive population.
The safety and efficacy of Isentress in HIV-positive
children and pregnant women have also yet to be
reviewed by the agency.
poz.com
The U.S. Food and Drug Administration (FDA) has
granted approval to Merck’s Isentress (raltegravir),
the first of a new class of HIV drugs known as
integrase inhibitors. Isentress, at a dose of one
400 mg tablet twice a day, has been approved
specifically for use in combination with other
antiretrovirals (ARVs) to treat treatment-
experienced HIV-positive patients with resistance to
multiple ARVs
The approval of Isentress is based on data from
two clinical trials involving 699 highly treatment
experienced HIV-positive adults. Isentress, when
combined with other approved ARVs, reduced viral
loads to undetectable in up to 62 percent of the
patients who received the drug, compared to 36
percent of those who received a placebo plus other
HIV drugs.
The side effects most commonly reported among
study volunteers who received Isentress were
diarrhea, nausea, and headache. Blood tests
showed abnormally elevated levels of a muscle
enzyme—creatine kinase—in some patients
receiving Isentress. According to the FDA,
Isentress should be used with caution by patients
who are at increased risk for muscle problems like
myopathy and rhabdomyolysis, which includes
patients using other medications known to cause
these conditions.
Isentress works by blocking HIV’s integrase
enzyme. After HIV's genetic material is deposited
inside a cell, its RNA must be converted (reverse
transcribed) into DNA. The integrase enzyme helps
to hide HIV's DNA inside the cell's DNA. Integrase
inhibitors stop this process and prevent HIV DNA
from meshing with healthy cell DNA.
While preliminary clinical trial results suggest that
Isentress is comparable to Sustiva (efavirenz)
among first-time treatment takers, it has not yet
been approved for this HIV-positive population.
The safety and efficacy of Isentress in HIV-positive
children and pregnant women have also yet to be
reviewed by the agency.
poz.com
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