Med Monitor

Gilead Sciences has announced a failed second attempt to craft a one-pill, once-daily regimen containing its anti-HIV drug Truvada with Bristol-Myers Squibb's Sustiva. An initial attempt to craft the one-pill therapy failed in April. Gilead and Roche plan to consider new ways to combine the drugs, including a layering approach. They hope to file for Food and Drug Administration approval of the single-pill treatment in the first half of 2006. __________ Abbott Laboratories has announced that it is working on a new tablet formulation of protease inhibitor Kaletra. The tablet formulation would reduce the pill burden from three to two pills per day and would not have to be refrigerated. __________ Roche and Trimeris have filed for FDA approval to use the Biojector 2000 device to administer the fusion inhibitor Fuzeon. The device uses a carbon dioxide-powered injector to spray liquid medication through the skin, which could reduce injection-site reactions. A decision by the FDA is expected by the end of the year. __________ Switching to Reyataz from other protease inhibitors maintains viral suppression and results in fewer viral rebounds, improved gastrointestinal tolerance, and significant lipid improvements, according to a study presented at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment. __________ Replacing Zerit with Viread can maintain virologic control while decreasing cardiovascular risks by lowering total cholesterol, 'bad' cholesterol, and triglyceride levels, according to a study discussed at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment. __________ A four-nucleoside regimen containing Viread and Trizivir following treatment failure with protease inhibitor- or nonnuke-based regimens is effective in reducing blood-based viral counts to below 400 copies in 87% of adults and to below 50 copies in 59% of adults, according to a study presented at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment. __________ A study discussed at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment has shown that Viread does affect kidney function but rarely causes overt renal failure. __________ The FDA has given fast-track approval designation to the experimental protease inhibitor GSK-640385, being developed by GlaxoSmithKline, based on data from a Phase IIa clinical trial showing the drug was effective against strains of HIV resistant to other protease inhibitors. __________ GlaxoSmithKline launched a final Phase III clinical trial of experimental fusion inhibitor aplaviroc, formerly known as GSK-873140. The drug works by binding CCR5 receptors on the surface of immune system cells, preventing HIV from latching on to them. __________ A six-month Phase II clinical trial of the Incyte experimental nucleoside reverse transcriptase inhibitor Reverset showed the drug reduced HIV viral loads by more than 90% in more than half of all study subjects who had built up resistance to other anti-HIV medications. __________ Phase II trial data for the Tibotec experimental protease inhibitor TMC 114 shows that a Norvir-boosted dose of the medication is effective as the cornerstone of salvage therapy for triple-class-experienced HIV patients, including those resistant to other protease inhibitors. __________ Officials from 26 drug companies and 11 Latin American countries reached a deal in August to slash prices of anti-HIV medications by as much as 66%. The price cuts will remain effective for two years.