Pharmaceutical Update

' The Food and Drug Administration has approved the use of Vfend, an antifungal medication for esophageal candidiasis, also called thrush. ' The FDA has given fast-track review status to a C31G, a vaginal microbicide that might prevent HIV infection, other sexually transmitted diseases, and pregnancy. A phase III clinical trial will begin early this year. ' VaxGen has announced that its HIV vaccine, AIDSVAX, failed to protect against HIV infection in a Phase III human trial in Thailand. The company announced similar results in February 2003 from a North American clinical trial. ' A study of the lipoatrophy treatment New-Fill has shown that the injectable synthetic polymer boosted median facial fat thickness measurements from nearly zero millimeters to seven millimeters in 50 patients treated over the course of 96 weeks. The FDA is expected to review New-Fill for marketing approval early this year. ' The Purefecta water purifier has been certified as being able to remove more than 99.99% of all bacteria, protozoa, and viruses from drinking water. All of these can cause illness in HIVers. ' French researchers warned in October that Kaletra should not be used in hemophiliacs who have other treatment options because the drug is associated with a threefold greater risk of bleeding than other protease inhibitors. ' A five-year study of Kaletra has shown that the protease inhibitor maintained HIV suppression in treatment-naive study subjects. No viral mutations conveying resistance to protease inhibitors were detected in any of the study volunteers. ' A study in the November 7 edition of the journal AIDS stated that antiretroviral therapy with Crixivan and Epivir (3TC) and Retrovir (AZT) maintained viral suppression and produced continuing CD4-cell increases in a majority of patients who took the drugs for six years. ' A five-year study of Ziagen has shown that adding the medication to an already successful antiretroviral regimen can further reduce viral replication and blood-based HIV viral loads. ' A study presented at the Ninth European Conference on AIDS showed that a once-daily regimen of Viramune, Videx, and Epivir suppresses HIV replication and boosts CD4-cell counts in treatment-naive patients who have a CD4-cell count greater than 100 at the start of therapy. ' Research presented at the Ninth European Conference on AIDS showed that a regimen containing once-daily dosing of Kaletra is as effective in reducing viral loads and boosting CD4-cell counts as twice-daily dosing of the medication. ' A German study has demonstrated antiretroviral therapy containing Trizivir or Combivir plus ritonavir-boosted Fortovase reduced viral loads to less than 50 copies in more than half of patients who began treatment with CD4-cell counts under 100 and viral loads over 50,000. ' The results from a 216-week study published in the October 15 edition of Clinical Infectious Diseases demonstrated that most patients who stick to a triple-drug regimen containing Crixivan maintain long-term immunological recovery and viral suppression. ' A study presented at the Ninth European Conference on AIDS showed that Videx maintains significant antiviral activity in patients with previous exposure to nucleoside reverse transcriptase inhibitors, including those previously treated with Videx. ' A study presented at the Ninth European Conference on AIDS reported that Viramunecan be safely substituted for Sustiva in patients unable to tolerate such Sustiva side effects as depression and sleep disturbances. ' Most patients using the fusion inhibitor Fuzeon for one year report that they were not negatively affected by the medication's twice-daily injection requirements, according to a study presented at the Ninth European Conference on AIDS. ' Gilead Sciences reported at the Ninth European Conference on AIDS that switching from Zerit to Viread results in a lowering of triglyceride and cholesterol levels. A separate four-year study of Viread showed that the drug has no significant risk of kidney toxicity, as measured through elevated creatinine levels. ' A 48-week study of Lexiva has revealed the protease inhibitor increases HDL, or 'good,' cholesterol levels. ' A Spanish study presented at the Ninth European Conference on AIDS said that high triglyceride levels return to normal within 12 weeks in one third of patients who switch from regimens containing Zerit to those with Viread. ' An 18-month study released in November showed the cholesterol drug Lipitor can halt, not just slow, the buildup of plaque in clogged arteries. ' A report in the November 7 issue of the journal AIDS documented an unusual hypersensitivity reaction to Ziagen that resembled the throat infection tonsillitis. Ziagen hypersensitivity, which is rare, is commonly marked by respiratory symptoms. ' Suboptimal blood-based drug levels are more common with Viramune than with Sustiva, according to a study presented at the Ninth European Conference on AIDS. ' A study in the October 12 edition of Journal of Infectious Diseases noted that Valtrex, a genital herpes treatment, is effective in delaying or preventing recurrent herpes outbreaks in HIV-positive adults. ' VIR201, a therapeutic HIV vaccine developed by Australian firm Virax, was shown in a small study to help control viral replication in people taking antiretroviral treatment breaks. ' Researchers at Panacos Pharmaceuticals have discovered a new compound, called PA-457, that interferes with the assembly of HIV's coating, leaving viral copies unable to infect other cells. Panacos plans to file an investigational-new-drug application with the FDA for the compound.