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Issue No. 51 | December 3, 2010

News and Features

FDA Approves INSTIā„¢ Rapid HIV Antibody Test

“On November 29, 2010, the Food and Drug Administration (FDA) announced the approval of the INSTI™ HIV-1 Antibody Test, a new, single use rapid test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The newly approved test provides results in as little as 60 seconds, in contrast to the six previously approved rapid HIV tests, which typically deliver results in about 10 - 20 minutes.

“Rapid HIV tests allow people to learn their HIV status in a single visit to a testing site, instead of returning days later for results, dramatically increasing the number of people who ultimately learn their serostatus after taking an HIV test.

“Rapid testing also helps increase access to HIV testing because testing can be performed outside of the traditional laboratory setting. Individuals who undergo testing can be counseled immediately concerning their HIV status and, if they are positive, given the opportunity to enter medical care.

“The INSTI™ HIV-1 Antibody Test can be used in clinical laboratories, in public health laboratories and in point-of-care settings.”

More information is available:

Study Suspended After Once-Daily Raltegravir (Isentress) Regimen is Demonstrated to be Less Effective Than Twice-Daily Regimen

“Taking the HIV drug Isentress once a day is not as effective as the standard twice-daily regimen, reported drug manufacturer Merck & Co. Based on these initial results, Merck is suspending the Phase III trial of once-daily dosing. Isentress is the only HIV drug that works by blocking integrase, an enzyme that allows HIV to insert its genetic material into human DNA. Taken twice a day, Isentress is used among both previously treated and treatment-naive HIV patients. The trial enrolled 775 patients who were taking other HIV medications in addition to Isentress. One subset received 800 milligrams of Isentress once-daily, another group received the standard 400-milligram dose twice per day. After 48 weeks, HIV was lowered to undetectable levels in 83.2 percent of patients on the once-daily regimen and 88.9 percent of patients on the twice-daily schedule.”

More information is available: