CD4 cell counts of 800 cells/mm3 or greater after 7 years of highly active antiretroviral therapy are feasible in most patients starting with 350 cells/mm3 or greater

Objective: CD4 cell count changes in therapy-naive patients were investigated during 7 years of highly active antiretroviral therapy (HAART) in an observational cohort. Methods: Three endpoints were studied: (1) time to >= 800 CD4 cells/mm(3) in 5299 therapy-naive patients starting HAART, (2) CD4 cell count changes during 7 years of uninterrupted HAART in a subset of 544 patients, and (3) reaching a plateau in CD4 cell restoration after 5 years of HAART in 366 virologically suppressed patients. Results: Among patients with < 50, 50 to 200, 200 to 350, 350 to 500, and >= 500 CD4 cells/mm(3) at baseline, respectively, 20%, 26%, 46%, 73%, and 87% reached >= 800 CD4 cells/mm(3) within 7 years of starting HAART. Periods with HIV RNA levels > 500 copies/mL and age >= 50 years were associated with lesser increases in CD4 cell counts between 6 months and 7 years. Having reached >= 800 CD4 cells/mm(3) at 5 years, age >= 50 years, and >= 1 HIV RNA measurement > 1000 copies/rnL between 5 and 7 years were associated with a plateau in CD4 cell restoration. Conclusions: Restoration to CD4 cell counts >= 800 cells/mm(3) is feasible within 7 years of HAART in most HIV-infected patients starting with >= 350 cells/mm(3) and achieving sufficient suppression of viral replication. Particularly in patients >= 50 years of age, it may be beneficial to start earlier than current guidelines recommend.