Switching treatment regimens at different viral load points yielded
similar outcomes in a cohort of children with
HIV, according to study results.
Researchers conducted a study to determine the long-term outcome of
protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor
(NNRTI) first-line antiretroviral therapy and viral load switch criteria in
children. The primary endpoint was change in viral load between baseline and 4
years as evaluated in an intention-to-treat analysis.
The treatment regimens were as follows:
- PI and switch to second-line at 1,000 copies/mL (PI-low; n=66)
- PI and switch to second line at 30,000 copies/mL (PI-higher;
- NNRTI and switch at 1,000 copies/mL (NNRTI-low; n=68)
- NNRTI and switch at 30,000 copies/mL (NNRTI-higher; n=67)
Results indicated that the median reductions in viral load were -3.16
log10 copies/mL for children in the PI group and -3.31
log10 copies/mL for NNRTIs, resulting in a difference of -0.15
log10 copies/mL (95% CI, -0.41 to 0.11).
Switching at a lower viral load yielded a mean reduction in viral load
of -3.26 log10 copies/mL compared with a reduction of -3.20
log10 copies/mL for switching at a higher viral load count. This
amounted to a difference of 0.06 log10 copies/mL (95% CI, -0.20 to
Resistance was uncommon in the PI group. No increase in NRTI resistance
was observed between the PI-higher and PI-low groups. NNRTI resistance was
selected early during viral rebound, according to the results.
Children in the NNRTI-higher group accumulated about 10% more mutations
than children in the NNRTI-low group.
New CDC stage-C events were observed in nine children. Sixty children
had grade 3-4 adverse events. These events were balanced across the study arms.
The trial was conducted between Sept. 25, 2002, and Sept. 7, 2005. The
median follow-up duration was 5 years (interquartile range, 4.2-6.0).
Of the 266 children randomly assigned initially, 71% were receiving
ART by the end of the trial.