Highly active antiretroviral therapy decreases mortality and morbidity in patients with advanced HIV disease

Background: Mortality and morbidity related to AIDS have decreased among HI V-infected patients taking highly active antiretroviral therapy (HAART), bu t previous studies may have been confounded by other changes in treatment. Objective: To assess the benefit of HAART in patients with advanced AIDS an d anemia. Design: Prospective, multicenter cohort study. Setting: The Viral Activation Transfusion Study (VATS), with enrollment fro m August 1995 through July 1998 and follow-up through June 1999. Patients: 528 HIV-infected patients with cytomegalovirus (CMV) seropositivi ty or disease who were receiving a first red blood cell transfusion for ane mia. Measurements: In a person-year analysis of follow-up before and after initi ation of HAART, Poisson regression was used to calculate crude rate ratios and rate ratios adjusted for CD4 count, HIV RNA level, calendar period, tim e on study, sex, ethnicity, and injection drug use. Results: At baseline, patients had a median CD4(+) lymphocyte count of 0.01 5 x 10(9) cell/L, median plasma HIV RNA level of 4.8 log(10) copies/mL, and median hemoglobin concentration of 73 g/L. Use of HAART increased from 1% of active patients in January 1996 to 79% of active patients in January 199 9. The crude death rate was 0.24 event/person-year among patients taking HA ART and 0.88 event/person-year among those not taking HAART (rate ratio, 0. 26; adjusted rate ratio, 0.38; P < 0.001 for both comparisons). Rates of no n-CMV disease were 0.15 event/ person-year after HAART and 0.45 event/perso n-year before HAART (crude rate ratio, 0.34 [P < 0.001]; adjusted rate rati o, 0.66 [P < 0.05]). Rates of CMV disease were 0.10 event/person-year after HAART and 0.25 before HAART (crude rate ratio, 0.42 [P < 0.01]; adjusted r ate ratio, 1.01 [P > 0.2]). Results were similar in patients with baseline CD4(+) lymphocyte counts less than 0.010 x 10(9) cells/L. Conclusions: The data support an independent reduction in mortality and opp ortunistic events attributable to HAART, even in patients with very advance d HIV disease. However, patients with CMV infection or disease may not have a reduction in new CMV events due to HAART.