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Session 16 Oral Abstracts
Implementing Antiretroviral Therapy in Developing Countries
Session Day and Time: Monday, 4 - 6 pm
Presentation Time: 4:30 pm
Room: Ballroom 5-6


64
Rapid Scale-up of Antiretroviral Services in Zambia: 1-year Clinical and Immunologic Outcomes
Moses Sinkala*1, J Levy2, I Zulu3, A Mwango1, E Stringer2, B Chi2, S Reid2, T Ellerbrock4, M Bulterys5, and J Stringer2
1Ministry of Hlth, Lusaka, Zambia; 2Univ of Alabama at Birmingham, Ctr for Infectious Disease Res, Lusaka, Zambia; 3Univ of Zambia Sch of Med; 4CDC, Atlanta, GA, US; and 5CDC, Lusaka, Zambia

Background:  Massive scale-up of HIV care and treatment services is currently underway in a number of developing countries. Whether these efforts will translate into favorable long-term outcomes is not fully known.

Methods:  We report on programmatic outcomes from 18 public and private clinical sites across 3 provinces of Zambia. Clinical care has been standardized according to national guidelines. Initiation of ART is dependent upon World Health Organization (WHO) clinical staging and CD4 cell count. First-line drug regimens are zidovudine (ZDV) or stavudine (d4T), plus lamivudine (3TC), plus nevirapine (NVP) or efavirenz (EFV). Individual-level outcomes data are collected through a computerized record system and standardized chart review.

Results:  From April 2004 to August 2005, we enrolled 18,075 adults into a government HIV care and treatment program, and started 11,074 (61%) on ART. Of those starting ART, 6806 (61%) were women. Among those commencing ART, mean CD4 was 131 (IQR 52 to182), mean body mass index was 21.3 (IQR 17.9 to 22.4), and 8009 patients (73%) were WHO stage III or IV. Over 81,248 patient-months, 1269 patients died (crude death rate 0.016 deaths/patient-month); 43% of deaths occurred in patients with entry CD4 £50 and 53% of deaths occurred within 60 days of enrollment. In a multivariable Cox regression, restricted to those on ART, risk of death was strongly associated with entry CD4+ count £50 (adjusted hazard ratio [AHR] = 2.1, 95%CI 1.8 to 2.4), WHO stage III or IV (AHR = 1.9, 95%CI 1.5 to 2.4), body mass index <16 (AHR = 2.2, 95%CI 1.8 to 2.5), hemoglobin <8 (AHR = 2.6, 95%CI 2.2 to 3.1), and male gender (AHR = 1.4, 95%CI 1.2 to 1.6). At least 6 months of follow-up was given 11,854 individuals to allow assessment of CD4 response. Those starting ART (n = 8284) had a greater mean increase in CD4 at 6 months (+61 vs +5 cells/mL; p <0.0001) and at 12 months (+85 vs –23 cells/mL; p <0.0001) than those not on ART. 

Conclusions:  Rapid initiation of ART in a programmatic setting led to favorable clinical outcomes at 6 and 12 months in Zambia. Advanced HIV disease was a very strong predictor of mortality in this population, suggesting that every effort should be made to identify and treat infected patients earlier in their disease course.