Pharmaceutical Update

Boehringer Ingelheim applied for Food and Drug Administration approval in late October of its protease inhibitor Tipranavir. A decision could come by the end of April. The company also filed for European Union approval. Boehringer Ingelheim launched an Expanded Access Program in November for Tipranavir while the drug is under review by the FDA. Indian drug firm Ranbaxy plans to submit three drugs'two different fixed-dose generic combinations of Epivir, Zerit, and Viramune and a two-drug combination pill of Epivir and Retrovir'to the FDA so the drugs can be purchased for the President's Emergency Plan for AIDS Relief. OraSure Technologies began a nationwide launch in November of its OraQuick Advance Rapid HIV-1/2 Antibody Test, which can produce results in about 20 minutes. Gilead Sciences halted production in October of two experimental anti-HIV drugs, protease inhibitor GS 9005 and nucleoside reverse transcriptase inhibitor GS 7340. GS 9005 was shown to have insufficient antiviral activity; GS 7340 was found to be too similar to existing drug Viread. Roche announced in November that it will not introduce its 625-milligram formulation of Viracept in Europe because of production problems. Company officials say they had difficulty making the film coating for the tablets. The 625-milligram version is marketed by Pfizer in the United States. Bristol-Myers Squibb wrote to U.S. health care providers in November to warn them of early virologic failure in treatment-naive patients who begin antiretroviral therapy with regimens that combine its drug Videx EC and Gilead Sciences' Viread with either the BMS drug Sustiva or with Boehringer Ingelheim's Viramune. Early drug failure was most common in patients with high baseline viral loads. A study presented at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy has shown that simultaneous administration of protease inhibitors Invirase and a booster dose of Norvir is needed for optimal Invirase absorption. Researchers reported at the 44th ICAAC that protease inhibitor Kaletra can deteriorate in hot climates. At 35 degrees Celsius (95 degrees Fahrenheit), Kaletra capsules became misshapen and drug content fell below 85% after 60 days. Changes were noticed within one day at 45 degrees Celsius (113 degrees Fahrenheit). A study in the online edition of Public Library of Science Medicine has shown that Viramune leads to higher increases in 'good' cholesterol than either Sustiva or lipid-controlling statin drugs. A study in the December 15 edition of The Journal of Infectious Diseases has shown that Zerit is safe and effective in preventing vertical HIV transmissions when given to pregnant women and their newborns. Researchers at the University of Buffalo have reported that the nucleotide reverse transcriptase inhibitor Viread does not alter the pharmacokinetics of methadone when given to recovering injection-drug users. A study presented at the Seventh International Congress on Drug Therapy in HIV Infection has suggested that HIV-positive children have better clinical outcomes and do not experience liver complications when treated with higher than recommended doses of Viramune. A study reported by Abbott Laboratories in November has shown that no primary protease inhibitor resistance was detected in any patient taking Kaletra for 300 weeks. Researchers reported in the September issue of Journal of Medical Virology that treatment with Fuzeon can hold CD4-cell counts steady or produce CD4-cell increases even when HIV viral loads remain high. A study released in October by Gilead Sciences has shown that treatment-naive HIV patients treated with a once-daily regimen of Viread, Emtriva, and Sustiva experienced fewer adverse side effects than those taking a regimen of twice-daily Combivir and once-daily Sustiva. Researchers reported at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy that a regimen of the three-in-one-pill Trizivir is as effective as regimens containing Combivir and Viramune. A study presented at the 44th ICAAC has shown that short-term treatment with Reyataz results in fewer metabolic disturbances than Kaletra therapy. U.K. drug regulators released a warning in November that taking protease inhibitors or antifungal agents along with lipid-lowering statin drugs, particularly Zocor and Lipitor, can boost risks for life-threatening muscle toxicity. Researchers at the University of Alabama have reported that once-weekly treatment with epoetin alfa'a synthetic protein sold as Procrit by Ortho Biotech Products and Epogen by Amgen'can boost hemoglobin levels and improve quality of life factors for HIV-positive adults experiencing anemia. A study presented at the Seventh International Congress on Drug Therapy in HIV Infection has shown that patients treated with the anabolic steroid Nandrolone experienced modest improvements in symptoms of HIV-related wasting.