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.
To respond to the HIV/AIDS epidemic in China, the National Center for AIDS/STD Control and Prevention established the Division of Treatment and Care in late 2001. The pilot for the National Free ART Program began in Henan Province in 2002, and the program fully began in 2003. Treatment efforts initially focused on patients infected through illicit blood and plasma donation in the mid-1990s and subsequently expanded to include HIV-infected injection drug users, commercial sex workers, pregnant women, and children. The National Free ART Database was established in late 2004, and includes data on current patients and those treated before 2004. Over 31 000 adult and pediatric patients have been treated thus far. Challenges for the program include integration of drug treatment services with ART, an under-resourced health care system, co-infections, stigma, discrimination, drug resistance, and procurement of second-line ART. The merging of national treatment and care, epidemiologic, and drug resistance databases will be critical for a better understanding of the epidemic, for earlier identification of patients requiring ART, and for improved patient follow-up. The Free ART Program has made considerable progress in providing the necessary care and treatment for HIV-infected people in China and has strong government support for continued improvement and expansion.
China's Free ART Program was initiated in 2002 as an emergency response to save and improve the lives of AIDS patients living mainly in impoverished rural regions of central China. With little experience in HIV/AIDS treatment and care and resource limitations, China's efforts to provide widespread access to free antiretroviral therapy has been a process fraught with difficulty. However, the Free ART Program is progressing from an emergency response to a standardized treatment and care system. The development of national guidelines, training programs, a laboratory support network, a national patient database, programs for special populations such as children and patients living with co-infections, and operational research has improved the scope and quality of the free treatment program. As of June 30, 2005, a total of 19,456 patients in 28 provinces, autonomous regions, and special municipalities had received free ART. Challenges stemming from the nature of China's health system and patient population persist, but with strong government support and a diverse set of resources, China has the capacity to overcome these challenges and to provide nationwide access to high quality treatment and care.
Background
In China, many former plasma donors (FPD) were infected with the human immunodeficiency virus (HIV) in the early-mid 1990s. Highly active antiretroviral therapy (HAART) was provided to FPDs beginning in 2002. The effect of HAART on mortality in this cohort has never been described.
Methods
Retrospective analysis of the national HIV epidemiology and treatment databases, from 1993–2006. All HIV-infected subjects from ten high HIV prevalence counties in six provinces were eligible. Inclusion criteria were: 1) plasma donation history, 2) Western blot positive, 3) clinical diagnosis of AIDS or CD4+ cell count <200/μl at any time, and 4) age ≥18 at AIDS diagnosis.
Results
Of 9059 eligible subjects, 4093 met the inclusion criteria. Mean age was 41 years, 51% were male, 99% were farmers, and 87% were from Henan Province. Overall mortality declined from 27.3/100 person-years in 2001 to 4.6/100 person-years in 2006. Conversely, the proportion of AIDS patient-years on HAART increased from 0% in 2001 to 70.5% in 2006. In a multivariate Cox proportional hazards analysis, the greatest risk factor for mortality was not receiving HAART, with a hazard ratio 2.8, 95% confidence interval 2.4–3.3. Among treated patients, those initiating therapy with lower CD4+ cell counts and higher numbers of opportunistic infections were at greater risk of death.
Conclusions
The national treatment program has significantly reduced the mortality rate among HIV-infected FPDs through the use of generic drugs in a rural treatment setting with limited laboratory monitoring. Treatment success can be improved through increased coverage and earlier initiation of therapy.
Background
Despite poor primary healthcare systems, free antiretroviral therapy (ART) has been available in China for over 5 years. Virologic outcomes of Chinese patients receiving ART have not been described at a national level.
Methods
A multi-stage cluster design was used in 8 provinces to randomly sample patients with at least 6 months on first-line ART, stratified by 3 treatment duration groups. Viral load testing and patient interviews were conducted and linked with national treatment database information. Data collected were analyzed for association with viral suppression using multivariable modeling. Adequate viral suppression was defined as viral load less than 400 copies/mL.
Results
Of 5,256 patients on ART, 3,894 patients met eligibility criteria from whom 1,153 were analyzed. Overall, 72% demonstrated viral suppression; of these, 82%, 73%, and 67% of participants on ART for 6–11 months, 12–23 months, and ≥24 months, respectively, showed viral suppression (p<0.001). In a multivariable model, treatment received at locations other than county level hospitals was less likely to achieve viral suppression, with greater odds for inadequate virologic response found at village clinics (odds ratio [OR] 5.4; 95% confidence interval [CI], 2.9–10.1), township health centers (OR, 3.1; CI, 1.7–5.6), and public health clinics (OR, 3.1; CI, 1.7–5.6). Patients receiving didanosine-based regimens were more likely to experience an inadequate virologic response than those receiving lamivudine-based regimens (OR, 3.9; CI, 2.7–5.7).
Conclusions
China’s national ART program is largely successful at suppressing viral load. Care received outside of hospitals and regimens containing didanosine were associated with less favorable virologic outcomes.
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