Canadian
researchers conducted a study to determine if such patients are at greater risk
of clinical events. Results were presented at the 46th Interscience Conference
on Antimicrobial Agents and Chemotherapy, taking place this week in San Francisco.
The
researchers studied a British Columbia cohort of antiretroviral-naive HIV positive
patients who initiated triple combination antiretroviral therapy between August
1996 and September 2003. The 299 analyzed subjects had baseline CD4 counts below
200 cells/mm3 and viral loads above 50 copies/mL, and had achieved 2 sequential
viral load measurements below 50 copies/mL within the first year of starting combination
therapy.
The
primary endpoint was non-accidental death or an AIDS-defining event. Subjects
were followed until death, progression to AIDS, viral load above 50 copies/mL,
or September 2004. The predictor of interest was whether the CD4 count 1 year
after starting HAART was below or above 200 cells/mm3.
Results
299 patients were followed for a median of 21 months (IQR 13-35).
97 patients (32.4%) did not attain a CD4 count of at least 200 cells/mm3 within
1 year of initiating antiretroviral therapy, while 202 subjects (67.6%) did.
10 of the 97 patients (10.3%) with CD4 counts below 200 cells/mm3 and 17 of those
(8.4%) with CD4 counts of 200 cells/mm3 or higher experienced clinical events
(P = 0.59).
Clinical events occurred at a median of 2.2 months after starting antiretroviral
therapy.
9 events occurred after 1 year of combination antiretroviral therapy: 4 (4.1%)
in the CD4 below 200 cells/mm3 group and 5 (2.5%) in the 200 cells/mm3 or higher
group (P = 0.48).
In Cox models for events after starting antiretroviral therapy, significant covariates
were:
- adherence of 95% or better (HR 0.34); - baseline CD4 count
(HR = 0.45/100 cells); - time-dependent CD4 count (HR 0.48/100 cells); -
failure to attain a CD4 count of at least 200 cells/mm3 (HR 3.08; P = 0.055).
In the Cox model for events after 1 year, failure to attain a CD4 of at least
200 cells/mm3 had some significance (HR 3.94; P = 0.08).
Conclusion
According
to the researchers, "HIV-infected patients on combination antiretroviral
therapy who achieve complete viral suppression but fail to attain CD4 [counts]
greater than or equal to 200 cells/mm3 have increased clinical events within the
first year of combination antiretroviral therapy."
If
the CD4 count did not rise to 200 cell/mm3 or higher after 1 year, they added,
"there remained an increased risk of clinical events thereafter."
Univ.
of Toronto, Canada; British Columbia Center. for Excellence in HIV/AIDS, Vancouver,
Canada.
09/29/06
Reference M
R Loutfy, B Yip, D Moore, and others. Increased clinical events in HIV-infected
patients who achieve full virologic suppression but fail to attain a CD4 count
? 200 cells/mm3 after one year of combination antiretroviral therapy (cART). 46th
Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco,
CA. September 27-30, 2006. Abstract H-1403.