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Pharmaceutical Update

Pharmaceutical Update


' GlaxoSmithKline and Vertex Pharmaceuticals' new protease inhibitor, Lexiva (fosamprenavir), received Food and Drug Administration approval on October 20. Lexiva is available in 700-milligram tablets, can be taken as one or two tablets either once or twice a day depending on dosing instructions, and has no food or water restrictions. ' The FDA granted full approval on August 29 for Serostim, Serono's recombinant growth hormone, for the treatment of AIDS-related wasting. The agency granted accelerated approval for the medication in April 1996. ' Fast-track review status was granted in October by the FDA for TNX-355, an experimental HIV fusion inhibitor developed by Tanox. A Phase II clinical trial will begin in the first half of 2004. ' The FDA gave expanded approval on September 9 for OraSure Technologies' OraQuick rapid HIV test to screen drawn whole blood samples for HIV antibodies. OraSure also has announced that it is seeking premarket FDA approval for the test to be used to detect HIV antibodies in saliva and blood plasma. ' Scientists at the University of California, San Francisco, have announced a yearlong study to examine the effectiveness of nucleotide analog Viread as pre-HIV exposure prophylaxis. The study, funded by the National Institutes of Health, will determine if daily dosing of the medication is effective in preventing HIV infections. ' Gilead Sciences warned U.S. health care providers in October that a regimen containing Viread in combination with Videx EC and Epivir provided poor virologic control and led to the development of drug-resistant virus. Gilead recommends patients currently taking that regimen be considered for a switch to a new combination. ' A GlaxoSmithKline study of a regimen containing Viread, Ziagen, and Epivir was halted after nearly half of participants experienced virologic failure after eight weeks of treatment. ' A study in the September 26 issue of the journal AIDS showed that after 48 weeks of treatment, only 43% of study subjects on a regimen containing Ziagen, Zerit, and Videx EC had undetectable viral loads. Side effects also were common, including neuropathy and increased lactate levels. ' Researchers in Spain reported in the September 11 issue of The New England Journal of Medicine that anti-HIV regimens containing Viramune, Sustiva, or Ziagen but not a protease inhibitor are effective treatment options for patients who have achieved virologic suppression on a protease inhibitor'based regimen. Protease inhibitor' naive subjects were not studied. ' Researchers reported in the August 2003 issue of Antiviral Therapy that a once-a-day regimen containing Videx EC, Epivir, and Sustiva is a safe and effective alternative to twice-daily regimens of two other anti-HIV combinations. ' A study presented at the 43rd ICAAC showed that Videx EC maintains significant anti-HIV activity among patients with virus resistant to other nucleoside analogs. ' Researchers reported in the September issue of the Annals of Internal Medicine that nucleotide analog Viread significantly reduced blood-based viral loads in patients experiencing resistance to nucleoside drugs. ' Trimeris and Roche second-generation fusion inhibitor T-1249 was shown in a Phase I/II clinical trial to reduce the viral loads of 73% of trial participants who had developed resistance to Fuzeon,> the companies' first fusion inhibitor. ' Data presented at the 43rd ICAAC showed that Viracept is safe and effective in treating HIV disease in patients coinfected with HIV and hepatitis C. ' Schering-Plough's new antifungal medication, Noxafil, was shown effective in 20 clinical and pharmacokinetic trials in fighting invasive fungal infections, including life-threatening infections in people with advanced HIV disease. ' Merck and Aventis have announced the beginning of human trials of a combination HIV vaccine. The studies will combine Merck's candidate, which uses a modified adenovirus to deliver HIV genes into the body, with Aventis's Alvac-HIV vaccine, which uses a canarypox virus to carry HIV genes to prime the immune system to recognize and attack HIV. ' A study in the September 5 edition of the journal AIDS showed that anti-HIV drug regimens containing Zerit or Crixivan are associated with an increased risk of developing diabetes. ' A study by researchers in Amsterdam showed that about 2.6% of patients starting an anti-HIV drug regimen containing the nonnucleoside Viramune experience acute hepatitis symptoms, including impaired liver function. ' An analysis of the records of more than 8,000 people taking Ziagen showed that about 5% experience a potentially life-threatening hypersensitivity reaction to the drug. ' A study in the August 15 edition of Journal of Infectious Diseases shows that although the corticosteroid prednisone helped reduce the side effects of interleukin-2 treatments in HIV-positive adults, the compound significantly decreased IL-2's ability to boost CD4-cell counts.

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