Benefits of enhanced infection prophylaxis at antiretroviral therapy initiation by cryptococcal antigen status

OBJECTIVES:To assess baseline prevalence of cryptococcal antigen (CrAg) positivity; and its contribution to reductions in all-cause mortality, deaths from cryptococcus and unknown causes, and new cryptococcal disease in the REALITY trial. DESIGN:Retrospective CrAg testing of baseline and week-4 plasma samples in all 1805 African adults/children with CD4 0.3). CONCLUSIONS:Relative reductions in cryptococcal disease/death did not depend on CrAg status. Deaths of unknown cause were unlikely to be cryptococcus-related; plausibly azithromycin contributed to their reduction. Findings support including 100 mg fluconazole in an enhanced-prophylaxis package at ART initiation where CrAg screening is unavailable/impractical.