Pharmaceutical Update

' The Food and Drug Administration has granted priority review status to Roche's application for a 500-milligram formulation of its protease inhibitor Invirase. ' Gilead Sciences has announced it will include Truvada, its new nucleoside reverse transcriptase inhibitor, in the company's U.S. patient assistance program. Gilead also will sell the drug, which combines Emtriva and Viread in a single pill, at a no-profit price in developing countries. ' A study by the San Francisco health department has shown that two antiretroviral regimens containing the nonnucleoside reverse transcriptase inhibitor Sustiva provide the highest survival rates out of 39 drug combinations studied. ' Higher doses of the protease inhibitor Kaletra could be beneficial to patients who have failed multiple anti-HIV regimens, according to a study done by researchers in Spain, France, and the United States. ' French researchers have reported that a maintenance regimen containing the anti-HIV drugs Sustiva and Viread, a nucleotide analog, is as effective as a three-drug cocktail in lowering HIV viral loads and boosting CD4-cell counts. ' Genetic tests have shown that after more than five years of treatment with Kaletra, no previously treatment-naive patients developed resistance to the protease inhibitor, U.S. researchers reported in July. ' U.S. researchers reported in July that a study of HIV patients participating in the early access program for the fusion inhibitor Fuzeon has shown that self-administered injections of the drug were well tolerated, including in patients with a history of injection-drug use. ' A study in the July 14 edition of The Journal of the American Medical Association showed that once-daily use of Emtriva, a nucleoside reverse transcriptase inhibitor, had a better virologic response, boosted CD4-cell counts higher, and was better tolerated than twice-daily Zerit. ' A study in the June edition of the journal Antiviral Therapy has shown that switching to a once-daily anti-HIV-drug regimen containing Videx, Viread, and Viramune might lower viral levels but could cause a drop in CD4 cells. ' A study in the July 3 edition of The Lancet indicated that HIV patients taking both Videx and Viread were 11 times more likely to develop pancreatitis than patients taking either drug alone. ' A South African study has shown that blood-based levels of Viramune are doubled in patients also taking the antifungal drug Diflucan, which increases the risk for Viramune-related liver toxicity. ' A study in the July 29 edition of The New England Journal of Medicine has shown the highest efficacy rate ever achieved for treating hepatitis C in HIV-coinfected patients by using both Pegasys (peginterferon) and Ribavirin. A 40% efficacy rate was reported. ' A Brazilian doctor reported in July that five years of follow-up of 441 HIV-positive men and 63 HIV-positive women who received two sessions of injections of a solution containing polymethylmethacrylate, a type of bone cement, to treat facial lipoatrophy, has shown the cosmetic surgical procedure to be safe, effective, and long-lasting. ' Supplements of the amino acid acetyl-L-carnitine have shown the ability to reverse nerve damage in people with antiretroviral-related neuropathy, according to a study in the July 23 edition of the journal AIDS. Increases in nerve numbers were seen in all study patients after six months. ' The blood-lipid'lowering medication fenofibrate'sold in the United States under the brand names Tricor and Lofibra'has shown the ability to be effective in treating hypertriglyceridemia, a condition associated with antiretrorival therapy, according to a study in the June edition of American Journal of Medical Sciences. ' Researchers from the Washington University School of Medicine reported in the August 1 issue of Clinical Infectious Diseases that extended-release niacin supplements might have the ability to lower blood-based lipid levels in people taking anti-HIV drugs. Total cholesterol levels fell 14%, and triglycerides were reduced 34% in some of the subjects studied. ' A study in the August 15 edition of The Journal of Infectious Diseases recommends against using prednisolone to treat HIV-associated pleural tuberculosis because the drug can boost the risks for developing Kaposi's sarcoma, a form of cancer that is associated with immune system deficiencies. ' Biotechnology company GenVec launched a Phase I clinical trial in July of an experimental HIV vaccine designed to prevent HIV disease progression to an AIDS diagnosis. It targets clades A, B, and C of the virus. ' U.S. researchers reported in July that a short study of an HIV microbicide containing a 1% concentration of Gilead Sciences' antiretroviral compound tenofovir has shown that no significant toxicity symptoms were associated with use of the product. ' Merck granted a license in July to South African generic drug firm Thembalami Pharmaceuticals to produce a generic version of efavirenz, sold in the United States as Sustiva.