Aptivus "Suboptimal" Comparator Arm Likely Key Issue For Antivirals Cmte.

The majority of comparator patients in the pivotal RESIST trials were resistant to their assigned agent, FDA says. The agency's reanalysis of the trials, however, continues to show statistical significance for tipranavir. Safety issues for Boehringer Ingelheim's HIV drug include hepatotoxicity and drug-drug interactions.