Two New Fusion Inhibitors Yield Good Early Results
Early studies show that two new fusion inhibitors may offer a "safe and effective alternative" to existing antiretroviral HIV therapies, Reuters Health reports. The compounds, T-20 and T-1249, are members of a class of drugs designed to block the virus before it can invade a cell and may be available by the end of next year, according to manufacturers Trimeris Inc. and Hoffman La-Roche (Reuters Health, 1/29). The drugs were designed for patients who have developed a resistance or intolerance to "standard treatment" and appear to "work well" in six new studies to be presented next week at the 8th Conference on Retroviruses and Opportunistic Infections. The first study, a Phase II trial, monitored T-20's effectiveness in reducing viral load in a group of 71 patients. The patients were divided into four groups, with each group receiving the "standard cocktail of three existing AIDS drugs," the Wall Street Journal reports. In addition, the control group received a placebo injection, while the other three groups received varying amounts of the T-20 compound. Patients who received T-20 "did better" than those who did not, with a subset of "seriously infected" patients demonstrating a "marked decline" in the amount of virus present in their blood (Harris, Wall Street Journal, 1/30). Researchers noted that the most reported side effect was irritation at the site of injection, occurring in two-thirds of the patients (Reuters Health, 1/29). Two additional studies observed T-20's effect in children ages 3 to 12. Children receiving the highest doses had a "marked reduction in their viral loads within seven days" and had no "serious adverse reactions" to the drug. Two more studies examined the "activity" of T-20 in test tubes. The final study tested T-1249 in 72 adults who had "given up" on standard antiretroviral therapy. In a two week study, participants had "measurable reductions" in viral load and tolerated the drug well. Two 500-patient, Phase III trials of T-20 are currently underway in Europe and the United States. Trimeris CEO Dr. Dani Bolognesi expects to have results in a year, and the FDA has promised to "quickly" review the studies. Bolognesi also expressed hope that the drugs would be available at an "affordable price" when they reach the market (Wall Street Journal, 1/30).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.