Different Baseline Characteristics and Different Outcomes of HIV-Infected Patients Receiving HAART Through Clinical Trials Compared With Routine Care in Mexico

Abstract

The efficacy of antiretroviral therapy (ART) has been established through clinical trials (CTs). However, selection bias and differences can limit their applicability to the general population. All treatment-naive HIV-infected patients who began ART in routine care (RC) between 2000 and 2008 were compared with all patients who initiated ART through a CT in terms of incidence of virological failure (VF), increase in CD4(+) count, mortality rate, and loss to follow-up (LTFU). At baseline, the RC group had less years of education, higher unemployment rate, higher proportion of females (14.2 vs. 5.7%; P < 0.01), lower median CD4(+) (97 vs. 158 cells/μL; P < 0.01), and lower proportion of patients with hemoglobin >12 g/dL (74 vs. 83%, P = 0.04). VF at week 48 was less frequent in the CT compared with the RC group (1.8% vs. 6.21%, P = 0.02). In multivariate analysis, participation in CT [odds ratio (OR): 0.20, 95% confidence interval (CI): 0.04 to 0.91, P = 0.03], hemoglobin >12 g/dL (OR: 0.29, 95% CI 0.09-0.89, P = 0.03), and receiving an optimal highly active antiretroviral therapy regimen (OR: 0.09, 95% CI: 0.01 to 0.52, P < 0.01) remained associated with lower risk of VF. All cause mortality was 0.017 (95% CI: 0.002 to 0.122) versus 0.094 (95% CI: 0.053 to 0.17) deaths per 1000 person-days in the CT group and in the RC group, respectively (P = 0.05). No differences were found in the proportion of patients LTFU. Receiving ART through CT was associated with lower probability of VF, lower mortality (probably related to less severe clinical characteristics at baseline), and similar rates of LTFU than RC.