Abstract
BACKGROUND: China's National Free Antiretroviral Treatment Program began in 2002 and, by August 2008, included over 52,000 patients. OBJECTIVE: To report five year outcomes on adult mortality and immunological treatment failure rates and risk factors. DESIGN: Open cohort analysis of prospectively collected observational database. PATIENTS: All patients in national treatment database from June 2002-August 2008. Patients excluded if not started on triple therapy or had missing treatment regimen information. INTERVENTION: Antiretroviral therapy per Chinese national treatment guidelines. MEASUREMENTS: Mortality rate and immunologic treatment failure rate using World Health Organization criteria. RESULTS: Of 52,191 total patients, 48,785 were included. Median age was 38 years, 58% were male, 53% were infected through plasma/blood, and median baseline CD4 cell count was 118/μL. Mortality was greatest during the first three months of treatment (22.6/100 person-years) but declined to a steady rate of 4-5/100 person-years after six months and maintained over the subsequent 4½ years. Baseline CD4 cell count <50/μL (adjusted hazard ratio [HR] 3.3, 95% confidence interval [CI] 2.9-3.8, compared to ≥200/μL) and having 4-5 baseline symptom categories (adjusted HR 3.4, 95% CI 2.9-4.0, compared to no baseline symptoms) were the strongest mortality risk factors. Treatment failure was determined among 31,070 with ≥1 follow-up CD4 cell count. Overall, 25% (12.0/100 person-years) failed treatment with the cumulative treatment failure rate increasing to 50% at five years. LIMITATION: Immunologic treatment failure does not necessarily correlate well with virologic treatment failure. CONCLUSIONS: The National Free Antiretroviral Treatment Program reduced mortality among adult AIDS patients in China to rates comparable to other low or middle-income countries. A cumulative immunological treatment failure rate of 50% after five years, with limited availability of second-line regimens, is of great concern.