Risk of progression to AIDS and death in women infected with HIV-1 initiating highly active antiretroviral treatment at different stages of disease

Background: The optimal virologic and immunologic stage at which to initiate antiretroviral therapy in individuals infected with human immunodeficiency virus type 1 (HIV-1) is undefined. Methods: Among 1054 HIV-1-infected women in a prospective cohort study, we determined the time from initiation of highly active antiretroviral treatment (HAART) to acquired immunodeficiency syndrome (AIDS) and death. Results: Median follow-up was 3.4 years. Of 553 women without AIDS at HAART initiation, 62 (11%) developed AIDS. Compared with women with CD4⁺ cell counts greater than 350/μL at HAART initiation, women with cell counts of 200 to 350/μL and less than 200/μL had relative hazards (RHs) for progression to AIDS of 0.93 (95% confidence interval [CI], 0.46-1.86) and 2.48 (95% CI, 1.39-4.42), respectively. Compared with those with HIV-1 RNA values less than 5000 copies/mL, women with 5000 to 50 000 copies/mL and greater than 50 000 copies/mL had RHs of 1.39 (95% CI, 0.74-2.64) and 2.09 (95% CI, 1.09-3.99), respectively. Among women with AIDS at HAART initiation (n=501), RHs of death were 1.97 (95% CI, 0.84-4.66) and 3.35 (95% CI, 1.59-7.08) with CD4⁺ cell counts of 200 to 350/μL and less than 200/μL, respectively, relative to those with greater than 350/μL, and 1.90 (95% CI, 0.84-4.30) and 3.70 (95% CI, 1.81-7.54) for those with HIV-1 RNA values of 5000 to 50 000 and greater than 50000 copies/mL, respectively, relative to those with less than 5000 copies/mL. Conclusions: Progression to AIDS and death was predicted by pre-HAART values of less than 200/μL for CD4⁺ cells and greater than 50 000 HIV-1 RNA copies/mL, indicating that deferral of HAART until the CD4⁺ cell count is between 350 and 200/μL is a valid strategy in the clinical management of HIV-1 infection.