Pharmaceutical Update

' The Food and Drug Administration has approved OraSure Technologies' OraQuick Rapid HIV-1/2 Antibody Test, which simultaneously detects antibodies to HIV-1 and HIV-2 in blood samples through finger sticks and blood draws. The test was previously approved to screen only for HIV-1. ' The FDA has approved HIV tests developed by Bayer and Roche that can detect viral genetic material in blood plasma. The Roche test, COBAS AmpliScreen HIV-1 Test v1.5, which is already used to screen whole blood, will also be used to screen organ donors. The Bayer test, which uses some of the same technology as the Roche test, will be used for in-house nucleic acid testing for HIV in plasma donations. ' Adventrx Pharmaceuticals has received clearance from the FDA to begin clinical studies of its HIV fusion inhibitor BlockAide/CR, a peptide-based drug. A Phase Ib/IIa trial is planned. ' HIV facial lipoatrophy treatment Sculptra, already sold overseas by Dermik Laboratories as New-Fill, has received unanimous approval with conditions by an FDA advisory committee. The conditions include a postapproval study, wording changes to the product label, and limiting its use to HIV-positive adults with facial wasting, among others. Sculptra is an injectable synthetic polymer derived from natural components. ' Gilead Sciences has submitted a New Drug Application to the FDA for marketing approval of a pill that combines nucleotide reverse transcriptase inhibitor Viread with nucleoside drug Emtriva. The proposed pill would be taken once daily in combination with at least one other anti-HIV drug. ' The FDA has added new information to the package insert for the protease inhibitor Reyataz. The additions warn of adverse interactions between Reyataz and Viread as well as adverse interactions between the drug and erectile dysfunction treatments Viagra, Levitra, and Cialis. ' A four-year follow-up study in the March 25 edition of the journal AIDS on the protease inhibitor Kaletra shows that the drug maintains a potent and durable anti-HIV effect over 48 months when dosed with Zerit and Epivir. Study subjects also did not develop resistance to any protease inhibitors during the study. ' Phase III trial data published in the March 5 edition of the journal AIDS shows that treatment-naive patients taking the protease inhibitor Lexiva with a small booster dose of Norvir for 48 weeks showed no signs of developing resistance to the drug or other protease inhibitors. Researchers say Lexiva's drug-resistance profile supports its use in early treatment regimens. ' Officials have reported that fusion inhibitor Fuzeon is now available at retail and specialty pharmacies nationwide and that production capacity has been expanded. ' Preliminary results from a study of HIV-positive adolescents in the United States presented at the 11th Conference on Retroviruses and Opportunistic Infections show that Fuzeon is safe and effective in reducing viral loads in heavily pretreated youths. ' Research presented at the 11th Conference on Retroviruses and Opportunistic Infections shows that Videx may help prevent HIV-related encephalopathy. Results showed Videx may have a specific effect on neurochemicals that reduces neuronal suffering, decreases choline levels, or both. ' A study in the April 2004 edition of British Journal of Clinical Pharmacology shows that blood-based levels of the protease inhibitor Kaletra are lower when the drug is given concurrently with either Sustiva or Viramune. The researchers have recommended therapeutic drug monitoring to optimize the dosing of Kaletra when used with the other anti-HIV medications. ' French researchers report in the March 1 issue of Journal of Acquired Immune Deficiency Syndromes that the use of nucleotide reverse transcriptase inhibitor Viread can lead to renal tubular dysfunction, particularly in patients with low body weight. Seven study subjects'six of whom weighed less than 60 kilograms (132 pounds)'showed signs of renal toxicity after five weeks to 16 months of treatment. ' A study of sex-based differences in responses to anti-HIV drugs has shown that blood-based concentrations of the protease inhibitor Invirase are higher among female study subjects than male study subjects after 16 weeks of treatment. The lower levels of Invirase in the blood of males translated to only 28% of male study subjects achieving a viral load below 500 copies, compared to 42% of females. ' A case study in the February 20 edition of the journal AIDS describes a 45-year-old HIV-positive man who developed a life-threatening hypersensitivity reaction half an hour after receiving a single dose of nucleoside reverse transcriptase inhibitor Ziagen. Hypersensitivity reactions occur in about 5% of adults taking Ziagen, but life-threatening reactions are rare. The researchers recommend physicians monitor all patients beginning Ziagen for symptoms of a severe allergic reaction, including dizziness, muscle pain, weakness, nausea, a sudden drop in blood pressure, and a rash on the body.