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

Fujie Zhang, MD; Zhihui Dou, MS; Ye Ma, MPH; Yan Zhao, MD, MS; Zhongfu Liu, PhD; Marc Bulterys, MD, PhD; and Ray Y. Chen, MD, MSPH
[+] Article and Author Information

From the National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention; Beijing Ditan Hospital; Global AIDS Program, U.S. Centers for Disease Control and Prevention; and the Office of Global Research, National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health, Beijing, China.


Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Department of Health and Human Services.

Acknowledgment: The authors thank the many HIV health care providers across China for their dedication in providing conscientious treatment and care to their patients and in completing the countless numbers of data forms that made this work possible. They also thank the many international institutions and organizations that have provided technical support to the National Free Antiretroviral Treatment Program over the past several years, including the World Health Organization; UNAIDS; Global Fund to Fight AIDS, Tuberculosis and Malaria; U.S. Centers for Disease Control and Prevention Global AIDS Program; National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health; Clinton Foundation; Pangaea Global AIDS Foundation; University of North Carolina at Chapel Hill; University of Maryland Institute of Human Virology; and Médecins Sans Frontières.

Grant Support: By the applied research program on AIDS prevention and treatment of the China Ministry of Health (grant WA-2006-03), the U.S. National Institutes of Health (grants U2R TW006918 and R03 TW008203), and a cooperative agreement from the U.S. Centers for Disease Control and Prevention Global AIDS Program to the Chinese Center for Disease Control and Prevention (grant 1U2GPS001188-01).

Potential Financial Conflicts of Interest: None disclosed.

Reproducible Research Statement:Study protocol, statistical code, and data set: Not available.

Requests for Single Reprints: Fujie Zhang, MD, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing 100050, People's Republic of China; e-mail, treatment@chinaaids.cn.

Current Author Addresses: Drs. Zhang, Zhao and Liu; Mr. Dou; and Ms. Ma: National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing 100050, People's Republic of China.

Dr. Bulterys: U.S. CDC Global AIDS Program—China Office, Suite 403-Dongwai Diplomatic Office, 23 Dongzhimenwai Dajie, Beijing 100600, People's Republic of China.

Dr. Chen: U.S. Embassy Beijing/NIH, No. 55 An Jia Lou Lu, Beijing 100600, People's Republic of China.

Author Contributions: Conception and design: F. Zhang, Z. Dou, Y. Ma, R.Y. Chen.

Analysis and interpretation of the data: F. Zhang, Z. Dou, Y. Ma, Y. Zhao, Z. Liu, M. Bulterys, R.Y. Chen.

Drafting of the article: R.Y. Chen.

Critical revision of the article for important intellectual content: F. Zhang, Z. Dou, M. Bulterys, R.Y. Chen.

Final approval of the article: F. Zhang, Z. Dou, Y. Ma, Y. Zhao, Z. Liu, M. Bulterys, R.Y. Chen.

Provision of study materials or patients: F. Zhang, Y. Ma.

Statistical expertise: Z. Dou, M. Bulterys.

Obtaining of funding: F. Zhang, Z. Liu, M. Bulterys.

Administrative, technical, or logistic support: Y. Zhao, Z. Liu.

Collection and assembly of data: Y. Ma, Y. Zhao, Z. Liu.


Ann Intern Med. 2009;151(4):241-251. doi:10.7326/0003-4819-151-4-200908180-00006
Text Size: A A A

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 0.118 × 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.

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.

Primary Funding Source: China Ministry of Health, U.S. National Institutes of Health, and U.S. Centers for Disease Control and Prevention Global AIDS Program.

Figures

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Figure 1.
Study flow diagram.

ART = antiretroviral therapy; AZT = zidovudine; d4T = stavudine.

* Categories not mutually exclusive.

† Active patients are those without a treatment termination date recorded who were last seen within 6 months of 30 August 2008. Late patients are those without a treatment termination date recorded who had not been seen within 6 months of 30 August 2008. Withdrawn patients are patients with a treatment termination date recorded for any reason.

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Figure 2.
Survival analysis.

HAART = highly active antiretroviral therapy. A. Overall change over time by mortality and life table survival rate. Mortality rate shown reflects each 3-month interval. B. Life table survival stratified by baseline CD4 cell count. C. Life table survival stratified by number of baseline symptom categories after treatment initiation for previously antiretroviral therapy–naive adult patients with AIDS.

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Figure 3.
Cumulative immunologic treatment failure rate and CD4 cell count response, stratified by treatment success and failure over time.

For the 31 070 patients with at least 1 follow-up CD4 cell count. HAART = highly active antiretroviral therapy.

* 119 738 were baseline counts; 281 797 were follow-up counts done within the first 6 months of treatment.

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Summary for Patients

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

The summary below is from the full report titled “Five-Year Outcomes of the China National Free Antiretroviral Treatment Program.” It is in the 18 August 2009 issue of Annals of Internal Medicine (volume 151, pages 241-251). The authors are F. Zhang, Z. Dou, Y. Ma, Y. Zhao, Z. Liu, M. Bulterys, and R.Y. Chen.

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