To describe the course of cytomegalovirus (CMV) retinitis in patients with AIDS in the era of highly active antiretroviral therapy (HAART). Multicenter, prospective, observational study. Two hundred seventy-one patients with AIDS and CMV retinitis. Follow-up every 3 months with medical history, ophthalmologic examination, laboratory testing, and fundus photographs. Photographs were evaluated for relapse of the retinitis (progression) by graders at a centralized reading center. Retinitis progression (movement of the border of a CMV lesion <750 μm over a <750-μm front or occurrence of a new lesion one-quarter disc area or more in size). The overall rate of retinitis progression was 0.10/person-year (PY); among those with CD4+ T-cell counts of <50/μl, it was 0.58/PY, compared to 0.02/PY among those with CD4+ T-cell counts of <200/μl (P<0.0001). In the multivariate analysis, significant risk factors for retinitis progression included a low CD4+ T-cell count, positive CMV load, longer time from AIDS diagnosis, and low Karnofsky score. Compared with the rate of retinitis progression (∼3.0/PY) reported in the pre-HAART era, the rate of retinitis progression was reduced among patients in the HAART era, even among those with low CD4+ T-cell counts, who might be expected to behave most like patients from the pre-HAART era. However, these events also occurred among patients with high CD4+ T-cell counts and presumed immune recovery. Continued ophthalmologic follow-up of patients with immune recovery is recommended to detect early retinitis progression. This article contains additional online-only material available at http://www.ophsource.com/ periodicals/ophtha.
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