Pharmaceutical Update

' The Food and Drug Administration approved new label information in late August for the nonnucleoside analog Sustiva. It indicates a Sustiva-based regimen is effective in suppressing HIV replication for at least three years. ' The FDA gave marketing approval in September for the spermicidal lubricant Amphora. Early clinical trials show the product helps prevent HIV, gonorrhea, herpes, and chlamydia infections. ' The FDA gave priority review status in October to Roche's application to market a combination of its hepatitis C treatments Pegasys and Copegus to patients coinfected with HIV and HCV. A decision is expected by February. ' Bristol-Myers Squibb has submitted a new-drug application to the FDA for its hepatitis B treatment entecavir. The antiviral has been shown to block three steps in HBV replication. An FDA decision may come by the spring. ' A study in the August 1 issue of Clinical Infectious Diseases has shown that once-daily dosing of Epivir is as effective as twice-daily dosing when given as part of a drug regimen also containing AZT and Sustiva. ' A study by researchers at the University of New Mexico has shown that blood-based levels of the protease inhibitor Fortovase, when boosted once daily with low doses of Norvir, are significantly higher in women than in men because of sex-related pharmacokinetic differences. ' Blood-based levels of the protease inhibitor Viracept are about 34% lower in pregnant HIV-positive women than in other HIV-positive females, researchers reported in the September 1 issue of Clinical Infectious Diseases. ' Study data presented at the 42nd Infectious Disease Society of America meeting have shown that heavily treated HIV patients who add fusion inhibitor Fuzeon to a drug regimen containing an active protease inhibitor are twice as likely to have a significant virologic response than those on a protease inhibitor'based regimen alone. ' Gilead Sciences reported in August that midterm data from a 48-week clinical trial have shown that a Sustiva-based regimen also containing its anti-HIV drugs Viread and Emtriva suppressed HIV levels to fewer than 400 copies in 88% of study participants, compared to 80% of those on a Sustiva-Combivir regimen. ' A study in the August edition of the European Journal of Clinical Investigation has shown that switching from a protease inhibitor to nonnucleoside analog Viramune significantly lowers triglycerides and boosts HDL, or 'good,' cholesterol levels after 24 weeks of treatment. ' A 96-week study of Fuzeon has shown that the fusion inhibitor was safe and generally well-tolerated by HIVpositive children ages 4 to 14. ' A study in the June 18 issue of the journal AIDS has shown that treatment with the nucleoside analog Videx EC and hydroxyurea produced higher HIV-specific CD8- and CD4-cell responses than a standard three-drug antiretroviral regimen. ' A study in the August 1 issue of Journal of Acquired Immune Deficiency Syndromes has shown that elevated lactate levels associated with the nucleoside analog Zerit improve after switching to another nucleoside drug. ' Researchers reported in July that coadministration of Videx EC and Viread raises the risk for pancreatitis. ' Researchers reported in the September 3 issue of the journal AIDS that HIV-HCV coinfected patients treated with PegIntron and Rebetol were more likely to have undetectable hepatitis C levels after six months than those treated with Intron A and Rebetol. ' Roche and Trimeris have launched Accelerated Simultaneous Access Program for the fusion inhibitor Fuzeon, through which patients taking an experimental anti-HIV drug are given up to a 60-day supply of the medication. ' The antifungal Micafungin is useful in treating HIV-related esophageal candidiasis, according to a study in the September 15 issue of Clinical Infectious Diseases. The drug was submitted in April for FDA approval for this use. ' A Thai study of the experimental therapeutic HIV vaccine Remune has shown that injections of the vaccine every 12 weeks for 132 weeks slowed HIV disease progression in 223 HIV-positive study subjects. ' Anormed halted development in October of its CXCR4 receptor inhibitor AMD3100 after a study showed only one of 40 test subjects had a significantly reduced viral level. ' Argos Therapeutics has announced upcoming human safety tests of an individualized HIV vaccine that uses the viral genes taken from an HIV-positive person to prompt an individualized immune system response. ' The October 14 edition of Science reported that researchers have developed an experimental HIV microbicide that blocks the CCR5 receptor, which HIV uses to infect human cells. The gel prevented vaginal HIV infections in monkeys. ' GlaxoSmithKline reached an agreement with the International Partnership for Microbicides in September to test its anti-HIV drugs for potential use in HIV microbicide gels.