Reduction in early mortality on antiretroviral therapy for adults in rural South Africa since change in CD4+ cell count eligibility criteria.

OBJECTIVE: To explore the impact of expanded eligibility criteria for antiretroviral therapy (ART) on median CD4⁺ cell count at ART initiation and early mortality on ART. METHODS: Analyses included all adults (≥16 years) initiated on first-line ART between August 2004 and July 2012. CD4⁺ cell count threshold 350 cells per microliter for all adults was implemented in August 2011. Early mortality was defined as any death within 91 days of ART initiation. Trends in baseline CD4⁺ cell count and early mortality were examined by year (August to July) of ART initiation. Competing risks analysis was used to examine early mortality. RESULTS: A total of 19,080 adults (67.6% female) initiated ART. Median CD4⁺ cell count at ART initiation was 110-120 cells per microliter over the first 6 years, increasing marginally to 145 cells per microliter in 2010-2011 and more significantly to 199 cells per microliter in 2011-2012. Overall, there were 875 deaths within 91 days of ART initiation; early mortality rate was 19.4 per 100 person-years [95% confidence interval (CI) 18.2 to 20.7]. After adjustment for sex, age, baseline CD4⁺ cell count, and concurrent tuberculosis (TB), there was a 46% decrease in early mortality for those who initiated ART in 2011-2012 compared with the reference period 2008-2009 (subhazard ratio, 0.54; 95% CI: 0.41 to 0.71). CONCLUSIONS: Since the expansion of eligibility criteria, there is evidence of earlier access to ART and a significant reduction in early mortality rate in this primary health care programme. These findings provide strong support for national ART policies and highlight the importance of earlier ART initiation for achieving reductions in HIV-related mortality