Objective: To determine the ability of intermediate plasma viral load (pVL)
measurements to predict virologic outcome at 52 weeks of follow-up in clin
ical trials of antiretroviral therapy.
Methods: Individual patient data from three clinical trials (INCAS, AVANTI-
2 and AVANTI-3) were combined into a single database. Virologic success was
defined to be plasma viral load (pVL) <500 copies/ml at week 52. The sensi
tivity and specificity of intermediate pVL measurements below the limit of
detection, 100, 500, 1000, and 5000 copies/ml to predict virologic success
were calculated.
Results: The sensitivity, specificity, and positive and negative predictive
values of a pVL measurement <1000 copies/ml at week 16 to predict virologi
c outcome at week 52 were 74%, 74%, 48%, and 90%, respectively, for patient
s on double therapy. For patients on triple therapy, the sensitivity, speci
ficity, and positive and negative predictive values of a pVL measurement <5
00 copies/ml at week 16 to predict virologic outcome were 68%, 68%, 80%, an
d 47%, respectively.
Conclusions: For patients receiving double therapy, a poor virologic result
, at an intermediate week of follow-up is a strong indicator of virologic f
ailure at 52 weeks whereas intermediate virologic success is no guarantee o
f success at 1 year. For patients on triple therapy, disappointing intermed
iate results do not preclude virologic success at 1 year and intermediate s
uccesses are more likely to be sustained.