“TB Biomarker Research Strategy:  The Way Forward”

Payam Nahid, MD, MPH, Associate Professor in Residence, UCSF School of Medicine

Abstract: There is renewed interest in shortening treatment duration for TB and a number of new agents are under investigation in clinical trials. However, establishing efficacy of a candidate drug within a regimen that includes other existing or new agents represents a significant challenge. There is mounting uncertainty about the current phase 2 intermediate endpoint used, the 2 month culture status. There is an urgent need for new biomarkers that can adequately assess drug efficacy, appropriate drug combinations, doses, and dosing frequencies to be selected for evaluation in phase 3 trials. The challenges and opportunities of TB biomarker research will be reviewed.