Operationalizing HIV Care in Africa
Charles B. Hicks, MD reviewing Mfinanga S et al. Lancet 2015 Mar 9.
In an open-label, randomized, controlled trial, screening and pre-emptive treatment for cryptococcal infection plus early adherence support after ART initiation significantly improved 1-year survival.
Although expanded access to antiretroviral therapy (ART) in Africa has greatly improved survival, early mortality after ART initiation remains high. Cryptococcal infection and tuberculosis (TB) account for most of the early deaths, and cost-effective strategies are needed to improve outcomes. In an open-label, controlled study conducted in Tanzania and Zambia, researchers assessed one such strategy: screening for cryptococcal antigen (CrAg) before ART initiation (and treating those with positive results) together with community-based early ART adherence support.
HIV-infected adults with CD4 counts <200 cells/mm3 were randomized to receive standard care or enhanced care (adherence support plus serum CrAg screening). Participants testing CrAg-positive were encouraged to undergo lumbar puncture and were treated with amphotericin and fluconazole if CrAg was detected in the cerebrospinal fluid; those who refused lumbar puncture or had negative results received fluconazole alone. ART initiation was delayed 2 weeks for individuals who were serum CrAg-positive; all others started immediately. Adherence support was done by trained lay workers and included up to four home visits.
In intent-to-treat analysis, 134 of 1001 intervention-group participants (13%) died within 12 months after ART initiation compared with 180 of 998 of standard-care–group participants (18%) — a 28% reduction (95% confidence interval, 11%–43%). In individuals with CD4 counts ≥50 cells/mm3, the mortality benefit was noted within the first 3 months, probably due to CrAg screening and pre-emptive treatment. (Overall, 4% of participants screened had positive CrAg tests, and these individuals had particularly high mortality rates.) In those with lower CD4 counts, the mortality benefit was seen later, probably due to improved adherence and consequent improved virologic/immunologic responses.
CITATION(S):
Mfinanga S et al. Cryptococcal meningitis screening and community-based early adherence support in people with advanced HIV infection starting antiretroviral therapy in Tanzania and Zambia: An open-label, randomised controlled trial. Lancet 2015 Mar 9; [e-pub].
