Defining Terms
Heavily Treatment Experienced (H.T.E.) Therapy
- a new/recycled drug REGIMEN used to treat pts who have experienced therapeutic failure (efficacy or safety)
- unlikely that a SINGLE new drug will suffice as “salvage therapy”
- for regulatory purposes, the contribution of a new DRUG to the regimen is of interest
- for clinical management strategies, the REGIMEN is the entity of interest
H.T.E. pts=previous rx with > 2 HAART regimens containing > 1 agent from each class (NRTIs, NNRTIs, PIs)