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No differences in 3-year outcomes after ART monitored by CD4 count vs. viral load
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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 presentation here.
“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 (P=.10).
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.
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