Gilead Sciences Inc. said
elvitegravir, a component in its four-drug HIV treatment Quad, showed similar
efficacy and tolerability compared to Merck & Co.’s Isentress in a two-year
trial.
The results of the study in
previously treated HIV patients were presented at the 19th International AIDS
Conference. In the late-stage clinical trial, elvitegravir met the primary
clinical goal of being non-inferior to Isentress, the researchers said.
“As patients are living with HIV
longer, there is a continued need for new treatment options, particularly those
that are effective against strains of the virus that have developed resistance
to currently available therapies,” said Dr. Richard Elion, lead investigator.
US and European health regulators
are reviewing elvitegravir for approval. The US Food and Drug Administration is
expected to make an approval decision on Quad in August.
Both once-daily elvitegravir and
twice-daily Isentress (raltegravir) are integrase inhibitors: They interfere
with HIV’s replication by thwarting its ability to integrate into the genetic
material of human cells.
Both treatment groups had similar
rates of adverse side effects, side effect-related discontinuations, and drug
resistance development; however, reports of diarrhea were more common among
study subjects taking elvitegravir (13 percent vs. 8 percent).
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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