BOSTON — Researchers observed no differences
between CD4 cell count monitoring only and standard CD4 cell count plus viral
load monitoring after 3 years of antiretroviral therapy. Therefore, the need
for viral load monitoring may not be as significant as monitoring for
adherence, tolerability and the safety and efficacy of antiretroviral therapy
in HIV-infected adults, according to Marc Lallemant, MD.
Lallemant, research associate in the department of
immunology and infectious diseases at Harvard School of Public Health,
presented findings from the phase-3, randomized PHPT-3 trial during a
“Problems occur at the beginning of therapy, which
has to be monitored individually,” he said. “Management of patients
is important and there is a need for third-line treatment because we know that
this third-line treatment will last as long as first-and second-line
treatment,” he said.
Researchers for the Program for HIV Prevention and
Treatment randomly assigned 716 previously ART-naive HIV-infected adults across
21 study sites in Thailand to either CD4 cell count monitoring only or to
standard CD4 cell count plus viral load monitoring. All participants initiated
combination ART with nucleoside reverse-transcriptase inhibitors and were
closely monitored and evaluated every 3 months.
Patients in the CD4 monitoring only group were switched
to a protease inhibitor-based second-line regimen when a 30% decrease in CD4
cell count was achieved; patients assigned standard monitoring were switched to
a second-line regimen when they achieved a viral load greater than 400
copies/mL, according to Lallemant.
At 3-years follow-up, overall survival was 96%.
Researchers observed 33 new AIDS-defining events, 22 deaths and three cases of
CD4 cell count decreases of 50 cells/mm³, for both arms combined.
Compared with a 7.5% rate in the number of patients who
switched to second-line therapy in the CD4-only monitoring group, 5.2% of
patients in the standard group switched to standard-line therapy
Moreover, median duration of a viral load greater than
400 copies/mL was only 7.2 months in the standard monitoring group vs. 15.8
months in the CD4 cell count monitoring-only group (P=.002). –
by Jennifer Henry
For more information:
- Lallemant M. #44. Presented at: 18th Conference on Retroviruses and
Opportunistic Infections; Feb. 27-March 3, 2011; Boston.