Report
3 - 4th International Workshop on HIV Drug Resistance and Treatment Strategies
Written by Jules Levin
Sitges, Spain, June 12-16 2000
Intermittent
Viral Load Blips and Viral Load Rebound
Diane
Havlir delivered an oral presentation on
intermittent viral load blips (HIV RNA 50-200) and if they are predictive of
virologic rebound (>200 copies/ml) in patients receiving initial combination
therapy.
She
defined intermittent viremia, for this study, as HIV RNA >50 copies/ml with a
subsequent measure <50 copies/ml after confirming virologic suppression
(<50 copies/ml) with 24 weeks of therapy with indinavir, AZT and 3TC.
Virologic rebound is 2 consecutive HIV RNA >200 copies/ml. (ACTG 343
maintenance failures were excluded). The median duration of therapy of the
patients in the study they used for this analysis (ACTG 343) was 84 weeks. In
ACTG 343 they found:
intermittent
blips (>50 c/ml) in 96/241 (40%)
intermittent
viremia (>200 copies/ml) in 47/241 (20%)
greater
than 1 episode (>50 c/ml) in 24/241 (10%)
2
consecutive HIV RNA (>50 c/ml) in 32/241 (13%)
Predictors
Of Intermittent Viremia (>50 c/ml)
Baseline
HIV RNA and maintenace therapy were predictors of blips. Baseline resistance at
215 position and time to <200 c/ml HIV RNA were borderline significant in
predicting blips.
They
used a modified Roche PCR viral load test with a low detection limit of 2.5
copies/ml. They found that median viral load was higher in subjects with
intermittent viremia (23 copies/ml) compared to those without intermittent
viremia (P<0.001). Only 8% of RNA measures in patients with intermittent
viremia were <2.5 copies/ml compared to 52% of patients without intermittent
viremia (P=0.013).
Havlir
concluded that in this study population in 343 intermittent blips did not lead
to viral rebound within the time frame they looked at (84 weeks): 9/96 (9.3%) of
patients with intermittent viremia had viral rebound; 20/145 (13.8%) with viral
suppression had viral rebound. Baseline HIV RNA was the only predictor of
virologic failure in the model they used.
They
also looked patients in the Merck 035 study in which patients received
indinavir+AZT/3TC. Again they found those with intermittent blips had higher
median RNA (7.3 copies/ml) than those with suppressed viremia (2.5 copies/ml).
But individuals with suppressed viremia also had blips, its just that they were
blips were <50 copies/ml. In this patient group with a median duration of 4.5
years of observation 0/6 patients with intermittent viremia had viral rebound,
and 0/7 patients with viral suppression had viral rebound.
Intermittent
viremia (>2.5 copies/ml) was present in all patients treated for as long as 5
years. One resistant researcher I spoke with at this meeting found resistant
virus when he observed blips. This resistant virus was not present before
therapy. He and I think it's intuitive that given enough time viral rebound will
occur if there are blips. Havlir's study extends to 5 years in small numbers of
individuals.
Why do
patients have persistent intermittent viremia? Havlir said it could be ongoing
infection, latently infected cells, and sanctuaries.