Background: China's National Free Antiretroviral Treatment Program began in 2002 and, by August 2008, included more than 52 000 patients.
Objective: To report 5-year outcomes on adult mortality and immunologic treatment failure rates and risk factors.
Design: Open cohort analysis of a prospectively collected, observational database.
Setting: China.
Patients: All patients in the national treatment database from June 2002 to August 2008. Patients were excluded if they had not started triple therapy or had missing treatment regimen information.
Intervention: Antiretroviral therapy according to Chinese national treatment guidelines.
Measurements: Mortality rate and immunologic treatment failure rate, according to World Health Organization criteria.
Results: Of 52 191 patients, 48 785 were included. Median age was 38 years, 58% were men, 53% were infected through plasma or blood, and the median baseline CD4 cell count was 0.118x10(9) cells/L. Mortality was greatest during the first 3 months of treatment (22.6 deaths per 100 person-years) but decreased to a steady rate of 4 to 5 deaths per 100 person-years after 6 months and maintained this rate over the subsequent 4.5 years. The strongest mortality risk factors were a baseline CD4 cell count less than 0.050x10(9) cells/L (adjusted hazard ratio [HR] compared with a count>or=0.200x10(9) cells/L, 3.3 [95% CI, 2.9 to 3.8]) and having 4 to 5 baseline symptom categories (adjusted HR compared with no baseline symptom categories, 3.4 [CI, 2.9 to 4.0]). Treatment failure was determined among 31 070 patients with 1 or more follow-up CD4 cell counts. Overall, treatment failed for 25% of patients (12.0 treatment failures per 100 person-years), with the cumulative treatment failure rate increasing to 50% at 5 years.
Limitation: Immunologic treatment failure does not necessarily correlate well with virologic treatment failure.
Conclusion: The National Free Antiretroviral Treatment Program reduced mortality among adult patients in China with AIDS to rates similar to those of other low- or middle-income countries. A cumulative immunologic treatment failure rate of 50% after 5 years, due to the limited availability of second-line regimens, is of great concern.