FDA approves first oral HIV antibody test. Food and Drug Administration

Health care experts say the first recently approved non-blood HIV test, OraSure, is a viable alterative to standard testing and is fast, safe, accurate, and painless. OraSure, developed by Epitope, Inc., and marketed by SmithKline Beecham Consumer Healthcare of Pittsburgh, tests an oral sample called oral mucosal transudate (OMT), rather than saliva. OMT, unlike saliva, contains high concentrations of antibodies and is free from contaminants. The test will be available at physicians' offices, private testing sites, public health departments, and community health services within 3 months. The cost is similar to a blood test. Food and Drug Administration (FDA) approval for the test was based on evidence that showed OraSure to be accurate 99.7 percent when compared to results from blood samples.     

FDA approves first viral-load test. Food and Drug Administration

The Food and Drug Administration (FDA) approved the viral-load test, Roche Molecular Systems' (RMS) Amplicor HIV-1 monitor, to be put on the market in July. The test uses polymerase chain reaction (PCR) technology, which amplifies and identifies specific DNA or RNA sequences and measures the efficacy of all three of the recently approved protease inhibitors. The test, the first of its kind to be approved, will sell for between $150 and $200, depending on individual laboratory fees. Although the test is expensive now, many are hopeful that more tests will receive FDA approval, thus driving down the price. Roche created an access program that will offer two free HIV RNA baseline tests to all HIV-positive patients in the United States during a 60-day period starting June 17.     

FDA approves new PCP drug. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) recently approved a suspension formulation of atovaquone (Mepron) for treating mild to moderate cases of pneumocystis carinii pneumonia (PCP) in patients intolerant of trimethoprim/sulfamethoxazole (TMP-SMX). The liquid form offers better bioavailability and convenient dosing. At least one study has shown that the drug is less toxic than intravenous pentamidine and may have possible action against microsporidiosis. The use of the suspension formulation for chronic preventive therapy against PCP also is being studied.     

FDA approves abacavir. Food and Drug Administration

The Food and Drug Administration (FDA) approved Glaxo Wellcome's nucleoside analog, abacavir (Ziagen, formerly 1592), for combination anti-HIV regimens for adults and children. In an early trial, abacavir was effective in suppressing HIV replication in combination with other antiretroviral drugs. Abacavir is generally well-tolerated, with minimal side effects. People who experience severe side effects within six weeks after starting abacavir should contact their doctor immediately. If medication is stopped due to severe hypersensitivity, it should not be restarted because it could result in a life-threatening reaction.     

FDA approves KS drug. Food and Drug Administration. Florida Department of Health and Rehabilitation Services

The Food and Drug Administration (FDA) approved injectable doxorubicin HCl liposome (DOXIL) for treatment of Kaposi's sarcoma (KS) in AIDS patients. DOXIL's major benefit is that its reported circulating half-life is fifty hours, compared to ten minutes for free (non-liposome) doxorubicin.     

FDA approves new rapid HIV test

The Food and Drug Administration has approved a new rapid HIV diagnostic test kit that provides results with 99.6% accuracy in as little as 20 minutes.     

FDA seeks temporary blood donor changes. Food and Drug Administration

The Food and Drug Administration (FDA) has requested that blood collection agencies exclude donors at risk of Group O HIV, following two cases identified in 1996. Group O is very rare in the United States. Blood donors would be excluded if they were born or lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger or Nigeria since 1977, or had sexual conduct with anyone traveling to those areas. The number of excluded donors would be minute.     

Food and Drug Administration requirements for approval of new anticancer drugs

For approval of new drugs, the law requires a minimum of two independent well-controlled studies for each indication. The preferred study design is prospective, randomized, and comparative. The use of historical controls, while sometimes acceptable, must be justified. A favorable effect on survival and/or quality of life is generally required for approval. The study of cancer drugs in combination presents problems which are discussed. Drug firms are strongly urged to discuss the protocols with the Food and Drug Administration prior to initiating phase III comparative studies to be used for approval of the drug.