The Chilean AIDS cohort: a model for evaluating the impact of an expanded access program to antiretroviral therapy in a middle-income country--organization and preliminary results.

Chile, middle-income country with 15 million people, began an expanded access program (EAP) to antiretroviral therapy (ART) in 2001. EAP provides ART, monitoring, and funding for management of associated complications in 32 points of care. A national cohort (Chilean AIDS Cohort [ChiAC]), enrolling 98% of these patients, was created for standardized treatment and impact evaluation. Information exchange is mainly through the Internet. By December 2004, the ChiAC had 4365 participants (83.3% male). At baseline, 47.5% had clinical AIDS, 26.2% were asymptomatic, 80.2% had a CD4 count <200 cells/mm and 58.2% were ART naive; in these patients, the most frequent regimen is zidovudine, lamivudine, and efavirenz. A 6-month follow-up in 1057 patients showed a global mortality of 5% (0.5% if patients were asymptomatic at baseline and 8.3% if patients had baseline AIDS). There was a similar risk of death if the baseline CD4 count was 100 to 200 cells/mm or >200 cells/mm ( approximately 1%), but this increased to 4.8% (relative risk [RR] = 5.2) and 10.7% (RR = 11.5) if the CD4 count was 51 to 100 cells/mm or <or=50 cells/mm, respectively. Discontinuation occurred in 7.7% of patients because of drug toxicity, and progression occurred in 2.9%. A successful EAP to ART with the resources of a middle-income country is possible. Early results are similar to those of industrialized countries. A national cohort allows better implementation and evaluation of the program and may be a useful model for other countries.