Zetia

OraQuick Rapid HIV-1 Antibody Test

(OraSure Technologies Inc.)

A single-use, rapid HIV antibody test that provides results in about 20 minutes; for use as a point-of-care test to aid in diagnosis of HIV-1 infection, from finger-stick whole blood specimens. The first HIV test that provides results almost immediately.

* Recommended Usage: After the blood sample is transferred into a vial with developer solution, a dipstick-like device with a small window is inserted into the vial; in about 20 minutes if the test is positive, two reddish-purple lines appear in the result window Results interpreted between 20 and 60 minutes.

* Special Considerations: Reactive tests need to be confirmed with a supplemental test (Western blot or immunofluorescence assay). No refrigeration required. Use is restricted to labs categorized by the Food and Drug Administration as "moderate complexity" under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Won't detect HIV if used within 3 months of exposure to the virus.

* Comment: In studies, the test's sensitivity was at least 99.6%, and specificity was 100%. It differs from a rapid HIV test approved in 1992, which requires a serum or plasma sample that is usually sent to a lab, requires refrigeration, and takes 47-108 minutes for results. The Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services are working with state and other health officials to make the new test widely available and to provide technical assistance and training in using the test.

Almost one-third of the estimated 1 million HIV-infected people in the United States have not been tested or have not returned for HIV test results, according to the CDC. A rapid HIV test addresses this issue "by providing results during the initial visit and enabling immediate counseling," the FDA noted in a summary of the test's safety and effectiveness. The test also can be used for the estimated 20% of pregnant women who don't know their HIV status at the time of delivery; this would permit treatment to be started during labor for women with positive tests and for their newborn infants, "substantially reducing the chance that infants will become infected with HIV" the FDA said. The rapid test also should be useful when health care workers are exposed to body fluids from HIV-infected patients.

OraSure, which is marketing the test with Abbott, is applying for a CLIA waiver so it can be used in more settings.

Zetia

(ezetimibe, Merck and Schering-Plough)

A cholesterol absorption inhibitor for use as adjunct to diet for reducing elevated total cholesterol, LDL cholesterol, and apo B in patients with primary (heterozygous familial and nonfamilial) hypercholesterolemia, either alone or with an HMGCoA reductase inhibitor. The first drug in a new class of cholesterol-lowering agents since the first statin was approved in 1987.

* Recommended Dosage: 10 mg once a day

* Special Considerations: Side effects in trials were similar in treated patients and those on placebo.

* Comment: Treatment with Zetia, which blocks cholesterol absorption in the intestinal tract, reduces LDL cholesterol by about 20%. The effect "is additive to statins ... and is comparable with tripling the dose of the statin, as far as efficacy is concerned," said Dr. Michael Davidson, director of preventive cardiology at Rush-Presbyterian--St. Luke's Medical Center, Chicago. He expects Zetia to be used mostly in combination with a statin, not only for getting patients to their National Cholesterol Education Program II target LDL cholesterol goal, but as monotherapy or for patients intolerant of stains.

Dr. Davidson was an investigator in an 8-week study of more than 700 patients with primary hypercholesterolemia with coronary heart disease or multiple cardiac risk factors, who were taking a statin but had not met their LDL cholesterol goal. Among those who had Zetia added to their treatment, 72% reached their goal, vs. 19% of those given a placebo. In trials, Zetia was well tolerated and easy to use, he noted.

Zetia costs about $1.93 per pill (catalog price for direct purchasers). This is "roughly equivalent" to adding 80 mg of a non-generic statin to 10 mg of the same statin, and provides similar efficacy said Dr. Davidson, who is on Merck's speakers' bureau.

COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group