Regimen could be the first to meet WHO criteria
REGIMEN COULD BE THE FIRST TO MEET WHO CRITERIA
The regimen we are proposing could be the first to meet the WHO criteria below for a pan-TB indication, being fully comprised of new agents unaffected by current resistance.
| Minimal | Optimal | |
|---|---|---|
| Purpose | Potential go/no-go decision point. | Needed to achieve greater global impact. |
| Indication | 1st-line treatment without the requirement of determining RIF resistance. | 1st-line treatment without the requirement of determining RIF resistance. |
| Population | Adults and children irrespective of HIV status. | Adults and children irrespective of HIV status. |
| Efficacy | Not inferior to RIF-S-TB standard of care in a 6-month regimen. | Not inferior to RIF-S-TB standard of care in a regimen of 4 months or less. |
| Safety & tolerability | Adverse events no worse than RIF-S standard of care. No more than monthly clinical monitoring and no laboratory monitoring for drug toxicity except in special populations. | Adverse events better than RIF-S standard of care. No active clinical monitoring and no laboratory monitoring for drug toxicity except in special populations. No ECG monitoring of QT interval required. |
