Early initiation of antiretroviral (ARV) therapy decreased mortality rates and TB incidence among Haitian patients, according to a new study. "Access to antiretroviral therapy should be expanded to include all HIV-infected adults who have CD4+ T-cell counts of less than 350 per cubic millimeter, including those who live in areas with limited resources," wrote Dr. Daniel W. Fitzgerald, of Weill Cornell Medical School in New York, and colleagues.
The open-label study lasted from 2005 to 2008 and involved 816 HIV patients with CD4+ T-cell counts greater than 200/mm3 and less than 350 (median=280/mm3). The patients were randomized into either an early-treatment group, initiating ARVs two weeks after enrollment, or a standard-treatment group, beginning ARVs when their CD4+ T-cell count fell to 200 or lower or when clinical AIDS developed. Both groups received zidovudine, lamivudine, and efavirenz upon initiating treatment and underwent monthly follow-up.
There were 23 deaths in the standard-treatment group, compared with six in the early-treatment group (hazard ratio with standard treatment, 4.0; 95 percent confidence interval [CI], 1.6 to 9.8; P=0.001). Incident TB cases stood at 36 among those receiving later treatment and 18 in the early-treatment group (hazard ratio, 2.0; 95 percent CI, 1.2 to 3.6; P=0.01).
The study also supports the World Health Organization's latest recommendation that people with HIV begin taking ARVs when their CD4+ T-cell count falls to 350. Details of the trial, "Early Versus Standard Antiretroviral Therapy for HIV-Infected Adults in Haiti," were published in the New England Journal of Medicine (2010;363(3):257-265).
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