The Weak Correlation Between Antibiotic Action and Mortality

At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the most important clinical endpoint[2]. FDA felt so strongly about this, Continue reading The Weak Correlation Between Antibiotic Action and Mortality

The Beauty of Science: No Need to Think About Costs When You Live in An Ivory Tower

The recently published INSIGHT trial showed that starting HIV therapy earlier rather than later has benefit for patients 1. This should not come as a surprise considering the excellent suppressive power of current triple regimens.  The trial which enrolled 4685 HIV infected patients was stopped prematurely when an interim analysis Continue reading The Beauty of Science: No Need to Think About Costs When You Live in An Ivory Tower

2014: The Year That Changed The Landscape of HCV Therapy

It was déjà vu all over again, albeit compressed in time: when the race started to replace PegIFN+RBV for the treatment of HCV infection, the learnings from HIV drug development and the lessons with HAART provided an excellent template for quick and efficient development. There was early consensus that a search Continue reading 2014: The Year That Changed The Landscape of HCV Therapy