When
Does CD4 Cell Count Plateau? Evidence from Patients Treated with Lopinavir/ritonavir
for up to 7 Years
It
is unclear how long subjects who receive long-term antiretroviral therapy can
maintain continued CD4 cell count
increases. Previous studies have generally suggested a plateau 3-4 years after
treatment initiation.
Researchers
from Abbott Laboratories analyzed CD4 cell count changes from baseline in 100
antiretroviral-naive subjects treated with lopinavir/ritonavir
(Kaletra) + d4T (stavudine; Zerit)
+ 3TC (lamivudine; Epivir) for
up to 7 years (360 weeks). Results were presented at the 46th Interscience Conference
on Antimicrobial Agents and Chemotherapy taking place this week in San Francisco.
The
investigators used nonlinear regression to fit a segmented model (by baseline
CD4 cell count strata) consisting of a quadratic model followed by a plateau.
Results
Mean baseline CD4 cell counts were 485, 129, and 24 cells/mm3, respectively, for
subjects with baseline CD4 counts greater than 200 cells/mm3 (n = 64), 50-199
cells/mm3 (n = 19), and below 50 cells/mm3 (n = 17).
The estimated plateau times (see figure below) were:
- 312 weeks in the
baseline CD4 greater than 200 cells/mm3 group, at a mean CD4 count of 957 cells/mm3; -
336 weeks in the CD4 50-199 cells/mm3 group, at a mean CD4 count of 633 cells/mm3;
- 371 weeks in the below 50 cells/mm3 group, at a mean CD4 count of 583 cells/mm3.
Results were similar if CD4 count change from baseline was used and if only study
completers were included.
Conclusion
"Based
on a model that explicitly identifies a time of CD4 plateau," the researchers
concluded, "antiretroviral-naive subjects treated with lopinavir/ritonavir-based
regimens with lower baseline CD4 counts had longer durations of CD4 increases
(up to 7 years for subjects with baseline CD4 below 50 cells/mm3), but CD4 values
did not catch up to those who started with higher CD4 counts at baseline."
They added that,
"Results compare favorably to [those of] previous studies that have suggested
CD4 plateaus at earlier timepoints, lower final CD4 counts, or both."
Abbott
Laboratories, Abbott Park, IL.
09/29/06
Reference M
King, B A Da Silva, F MCMillan, and others. When does the CD4 cell count plateau?
Evidence from subjects treated with a lopinavir/ritonavir-based regimen for up
to 7 years. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy.
San Francisco, CA. September 27-30, 2006. Abstract H-1401.