Five-Year Outcomes of the China National Free Antiretroviral Treatment Program

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Abstract
China's National Free Antiretroviral Treatment Program began in 2002 and, by August 2008, included more than 52 000 patients. To report 5-year outcomes on adult mortality and immunologic treatment failure rates and risk factors. Open cohort analysis of a prospectively collected, observational database. China. 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. Antiretroviral therapy according to Chinese national treatment guidelines. Mortality rate and immunologic treatment failure rate, according to World Health Organization criteria. 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 0.118 × 109 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 0.050 × 109 cells/L (adjusted hazard ratio [HR] compared with a count ≥0.200 × 109 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. Immunologic treatment failure does not necessarily correlate well with virologic treatment failure. 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. China Ministry of Health, U.S. National Institutes of Health, and U.S. Centers for Disease Control and Prevention Global AIDS Program.

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