Pharmaceutical Update

' Gilead Sciences announced in August that its combination anti-HIV medicationTruvada received accelerated marketing approval by the Food and Drug Administration. Truvada combines the company's previously approved drugs Emtriva and Viread into a single fixed-dose pill that is taken once daily in combination with other anti-HIV drugs. ' The FDA in August approved the combination anti-HIV drug Epzicom, from GlaxoSmithKline. Epzicom combines the company's previously approved drugs Ziagen and Epivir into a single fixed-dose pill that is taken once daily in combination with other anti-HIV drugs. ' The FDA in August approved Sculptra, a synthetic compound developed by Dermik Laboratories, to treat HIV-related facial lipoatrophy. The injectable poly-L-lactic acid will be available during the third quarter of 2004. ' Agouron has announced a 625-milligram formulation of the protease inhibitor Viracept. The new dosage allows patients to take two Viracept pills twice daily instead of five pills twice daily with the older 250-milligram formulation. ' Abbott Laboratories submitted a new drug application to the FDA in July for approval of once-daily dosage of the protease inhibitor Kaletra. If approved, Kaletra would be taken via six pills once daily with food instead of the current three pills twice daily. ' Roche submitted a new drug application to the U.S. Food and Drug Administration in June for a 500-milligram formulation of the protease inhibitor Invirase. The new formulation would reduce pill dosing to two pills twice daily. ' The FDA approved new label information in July for Reyataz, the Bristol-Myers Squibb protease inhibitor. The new information includes data showing Norvir-boosted Reyataz is as effective in reducing viral loads as Kaletra but has less impact on lipid levels. ' The FDA in July updated the box warning for Viread, Gilead Sciences' nucleotide reverse transcriptase inhibitor, to state that the safety of the drug for HIV patients coinfected with hepatitis B has not been established. The changes include a warning that some coinfected patients discontinuing Viread have suffered severe acute exacerbation of hepatitis B. ' An experimental viral load test by Norway-based Bionor, called Real-Time Immuno-PCR Test, has been shown in studies to be 25 times more sensitive than currently available tests'able to detect as few as two viral copies. ' Serono has announced a Phase III clinical trial of human growth hormone Serostim to reduce HIV-related visceral fat accumulation in the abdomen and upper back. ' OraSure Technologies has announced that its OraQuick Rapid HIV Antibody Test has been approved by the FDA to screen for HIV type 2 in addition to its previous approval to test for HIV type 1. Following the approval, the Department of Health and Human Services approved the use of the HIV-1/2 test in about 180,000 nonlaboratory sites. The manufacturer says the test produces results from oral fluids or blood from finger sticks in about 20 minutes. ' Trinity Biotech's Uni-Gold Recombigen HIV test, which reportedly can detect HIV antibodies in whole blood, serum, or plasma in about 10 minutes, was approved by the FDA in July for use in about 200,000 nonhospital settings, including clinics and doctors' offices. ' Study data on the Roche protease inhibitor Invirase, presented at the 15th International AIDS Conference, held in July, shows once-daily, Norvir-boosted Invirase dropped HIV viral levels to fewer than 50 copies in 91% of patients who had been taking it for 24 weeks. CD4-cell counts climbed an average of 109 cells. ' A study in the June 1 issue of Journal of Acquired Immune Deficiency Syndromes reports that switching from protease inhibitor Viracept to Reyataz maintains viral suppression for at least 36 weeks and significantly reduces elevated lipid levels after 12 weeks. ' Data from a three-year study in the July 14 edition of The Journal of the American Medical Association shows that nucleotide reverse transcriptase inhibitor Viread is as effective as Zerit but is associated with a better lipid profile and lower incidence of lipodystrophy. ' A study presented at the 15th International AIDS Conference shows protease inhibitors Lexiva, from GlaxoSmithKline, and Kaletra, from Abbott Laboratories, are effective in treating patients who have failed one or two prior protease inhibitor'based antiretroviral regimens. ' HIV patients taking the protease inhibitor Kaletra experience drug-related diarrhea at about one third the rate as those taking Viracept, according to a study in the June edition of the journal Pharmacotherapy. ' Officials in Thailand announced in June that a Phase III HIV vaccine trial combining AIDSVAX, from VaxGen, and ALVAC, from Aventis Pasteur, will be delayed by one year because of difficulties in recruiting 16,000 volunteers. ' Boehringer Ingelheim announced a compassionate-use program in June to provide up to 10,000 HIV-positive people with tipranavir, an experimental protease inhibitor. The drug is in Phase III clinical trials. The company has also released Phase IIb clinical trial data showing Norvir-boosted tipranavir is safe and well-tolerated.