Cytomegalovirus retinitis in advanced HIV-infected patients treated with protease inhibitors: Incidence and outcome over 2 years

We prospectively studied the incidence of cytomegalovirus (CMV) retinitis i n 93 patients treated with highly active antiretroviral therapy (HAART) con taining a protease inhibitor (PI), during a median follow-up period of 24 m onths. The median initial CD4(+) count was 22 cells/mu l (range, 1-311 cell s/mu l), and the median plasma HIV viral load was 5.1 log(10) copies/ml (ra nge, 2.4-6.4 log(10) copies/ml). The fundus was examined monthly in patient s with a history of CMV retinitis or an initial CD4(+) count <50 cells/mu l and every 3 months in the other patients. Of patients with previously cont rolled CMV retinitis, 1 of 7 relapsed. In addition, 6 of 59 patients with a CD4(+) count <50 cells/mu l and no history of CMV retinitis before startin g PI therapy developed CMV retinitis. Of them, 3 had at least one relapse d uring follow-up. CD4(+) counts were <40 cells/mu l at the time of primary o r recurrent CMV retinitis, except in two cases (147 cells/mu l and 203 cell s/mu l). In conclusion, the incidence of CMV retinitis was 0.091 per patien t-year among study subjects with advanced HIV infection who were receiving HAART (95% confidence interval [CI], 0.037-0.145). The lime to progression of CMV retinitis (mean, 215 days; 95% CI, 113-317 days) was longer than rep orted be fore widespread use of PIs.