Pharmaceutical Update

' The Department of Health and Human Services has announced an expedited drug-review process for fixed-dose combination pills containing one or more anti-HIV medications already approved by the agency and for generic drugs, including combination pills, designed for use in developing nations. ' The Food and Drug Administration gave traditional approval status in April to GlaxoSmithKline nucleoside reverse transcriptase inhibitor Ziagen. The FDA initially approved the drug in December 1998 under the agency's accelerated approval regulations. ' The FDA is expected to announce before the end of the year the approval of GlaxoSmithKline's single pill combining the company's Epivir and Ziagen antiretrovirals, each of which have been separately approved by the agency. The combination pill will be taken once daily. ' The FDA gave priority review status in May to Gilead Sciences' single pill combining the company's Viread and Emtriva antiretroviral medications, each of which have been separately approved by the FDA. A decision by the agency is expected by September 12. ' Pfizer has announced the availability of its protease inhibitor Viracept in a 625-milligram pill, enabling users of the medication to take two pills twice a day'instead of five pills twice a day with the older 250-milligram formulation. ' Drugmakers Bristol-Myers Squibb, Gilead Sciences, and Merck have announced the joint development of a once-daily pill combining a full day's doses of three anti-HIV drugs'Viread, Emtriva, and Sustiva. There was no report as to when the pill would be ready for human testing. ''Roche and Trimeris have announced that their fusion inhibitor, Fuzeon, previously available only through a progressive distribution program, has been made available by prescription at all U.S. pharmacies. ' Gilead Sciences has announced an expansion and simplification of its patient assistance program. The program now provides access to antiretroviral drugs on the same day a prescription is received for the company's drugs, including anti-HIV medications Viread and Emtriva and the hepatitis B treatment Hepsera. ''Boehringer Ingelheim has announced the expansion of its U.S. Open Label Safety Study of its experimental nonpeptidic protease inhibitor, tipranavir, to provide the drug to 50 more patients a month. The expansion broadens the study entry criteria and also doubles the number of OLSS sites nationwide from 33 to 66. ' A study presented at the 10th Anniversary Conference of the British HIV Association shows that trough levels of the protease inhibitor Kaletra, marketed by Abbott Laboratories, are significantly higher in men with low body weight. There were too few women studied to link body weight with blood-based levels of Kaletra in women. ' A panel of HIV experts has released international guidelines for treating HIV-positive adults with the fusion inhibitor Fuzeon.The panel recommends that Fuzeon be given to patients with CD4-cell counts of at least 100 cells and those still responsive to at least two other anti-HIV medications whenever possible. ' Switching from other protease inhibitors to Reyataz, marketed by Bristol-Myers Squibb, can result in rapid improvements in lipodystrophy-associated body shape changes and high blood-lipid levels, according to a study in the April 9 edition of the journal AIDS. ' A study in the April 30 edition of the journal AIDS shows that fat loss from the limbs linked with the use of antiretroviral drugs can be reversed in the long term by switching from Retrovir or Zerit to Ziagen. ' Doctors in South Africa report in the April 30 issue of the journal AIDS the first case of Kaletra failure in a protease-inhibitor'naive individual linked to cross-resistance to other protease drugs. ' A study by researchers in Paris shows that severe cases of kidney toxicity related to use of Gilead Sciences' Viread are rare and reversible once the medication is stopped. The study also shows that risk factors for Viread-related renal problems include taking the drug with the protease inhibitor Norvir and having preexisting kidney deficiencies. ' Treating hepatitis C with pegylated interferon and ribavirin during the first six months of infection can lead to a high rate of viral clearance in adults coinfected with HIV, according to a study presented at the 10th Anniversary Conference of the British HIV Association. ' A study in the May 19 edition of the journal Annals of Internal Medicine shows that GlaxoSmithKline diabetes drug Avandia can improve insulin sensitivity and lessen lipodystrophy symptoms in people taking antiretroviral drugs. ' Researchers report in the May 5 online edition of the journal BMC Medicine that prednisolone can slow the loss of CD4 cells in HIV-positive people. Prednisolone, a corticosteroid, boosted CD4 counts by more than 200 cells during the first two weeks of treatment and on average kept cell counts elevated for at least two years.