Five-year outcomes of the China National Free Antiretroviral Treatment Program

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.

Figure 1

Schematic diagram of the 52,191 total patients in the National Free Antiretroviral Treatment Program, China, June 2002 – August 2008. Note: Active patients are those without a treatment termination date recorded who were last seen within six months of August 30, 2008. Late patients are those without a treatment termination date recorded but had not been seen within six months of August 30, 2008. Withdrawn patients are patients with a treatment termination date recorded for any reason.

Figure 2

Overall change over time by mortality and life table survival rate (2a) and life table survival stratified by baseline CD4 cell count and number of baseline symptom categories (2b) following treatment initiation for previously antiretroviral therapy naïve adult AIDS patients in the National Free Antiretroviral Treatment Program, China, June 2002 – August 2008. Mortality rate shown reflects each three month interval.

Figure 2

Overall change over time by mortality and life table survival rate (2a) and life table survival stratified by baseline CD4 cell count and number of baseline symptom categories (2b) following treatment initiation for previously antiretroviral therapy naïve adult AIDS patients in the National Free Antiretroviral Treatment Program, China, June 2002 – August 2008. Mortality rate shown reflects each three month interval.

Figure 3

Cumulative immunological treatment failure rate and CD4 cell count response stratified by treatment success and failure over time among the 31,070 patients with at least one follow-up CD4 cell count in the National Free Antiretroviral Treatment Program, China, June 2002 – August 2008. CD4 cell counts over time were modeled using the mixed linear model with maximum likelihood estimation.