Portal de Periódicos da CAPES

Low Rate of CMV End-Organ Disease in HIV-Infected Patients Despite Low CD4+ Cell Counts and CMV Viremia: Results of ACTG Protocol A5030

2009; Taylor & Francis; Volume: 10; Issue: 3 Linguagem: Inglês

10.1310/hct1003-143

1945-5771

David A. Wohl, Michelle A. Kendall, Janet Andersen, Clyde S. Crumpacker, Stephen A. Spector, Judith Feinberg, Beverly Alston‐Smith, Susan Owens, Suzette Chafey, Michael R. Marco, Sharon Maxwell, Nell S. Lurain, Douglas A. Jabs, Constance A. Benson, P. Keiser, Mark Z. Jacobson,

Systemic Lupus Erythematosus Research

Purpose: To describe cytomegalovirus (CMV) end-organ disease (EOD) rate in AIDS patients with low CD4+ cell count despite HAART who were enrolled in a randomized, placebo-controlled trial of preemptive valganciclovir (VGCV) to prevent CMV EOD in those with CMV viremia. Methods: Subjects (N = 338) were HIV-infected with CD4+ count 400 copies/mL, and on stable or no HAART. All underwent plasma CMV DNA PCR testing every 8 weeks (Step 1); those with detectable CMV DNA were randomized to VGCV or placebo (Step 2). Results: Plasma CMV DNA was detected in 68 (20%), of whom 4 developed CMV EOD. During Step 1, 53 died. Of the 47 who entered Step 2 (24 VGCV, 23 placebo), CMV EOD was diagnosed in 10 (4 VGCV, 6 placebo) and 15 died (7 VGCV, 8 placebo). Of those randomized to placebo, 14% were diagnosed with CMV EOD at 12 months. Conclusions: We observed a lower CMV EOD rate among subjects receiving HAART than predicted based on published literature. However, mortality was high in this study. Our findings suggest that preemptive anti-CMV therapy in patients with persistently low CD4+ cell counts in the current treatment era may not be warranted given the low incidence of CMV EOD and high all-cause mortality observed in this study population.