Houston is home to the Astros and Rockets, but in April it hosted nearly 50 high-flying stars in HIV research and activism who gathered to brainstorm how to better serve multidrug-resistant (MDR) HIVers who desperately need new treatment options (see “The Clockwatchers,” POZ, October 2003). The message was familiar: The best hope for MDR HIVers is getting them two or more brand-new drugs at a time (and ASAP!) to try to overpower dense resistance. But drugmakers—each pursuing data to move its own drug toward approval—have done little to synchronize research toward that goal, even though the FDA long ago gave them the green light.
At one point, all eyes were on Eric Lefebvre, MD, from the smallish pharma Tibotec. Tibotec has two new candidates—the protease inhibitor (PI) TMC 114 and the non-nuke TMC 125—in similar development stages (both in Phase IIb, where dosing levels are determined), hence a rare chance to test them together in MDR HIVers. Would they? “The commitment is there,” Lefebvre ventured. POZ followed up in May, when Tibotec VP Karen Manson confirmed that the company was “already planning to study” both drugs together and “will not need to be encouraged…to initiate [a trial] at the earliest practical moment.”
But Rob Camp of the AIDS Treatment Activist Coalition (ATAC), which aims to represent HIVers in the drug-development process, disagrees: “Although they feel they don’t need encouragement, I encourage them to speed up in order to initiate a combo study by September 2004.”
Option-needy HIVers, let Tibotec know how much you’re counting on them at www.tibotecvirco.com.