Effect of Adding Raltegravir to Intensify ART in Advanced HIV Disease in Africa: Results of the REALITY Trial

Adding raltegravir to initial standard three-drug ART for advanced HIV disease in Africa provided no clinical benefit.

The risk for death after starting potent ART in sub-Saharan Africa for persons with advanced HIV disease remains high (about 10%). Initial treatment in that setting is complicated by the risk for the immune reconstitution inflammatory syndrome (IRIS). In this study, researchers evaluated whether adding raltegravir (a well-tolerated drug associated with rapid decrease in HIV levels) to standard three-drug ART would improve clinical outcomes. In a 2×2×2 factorial, open-label, parallel-group trial, treatment-naive HIV+ persons aged ≥5 years with CD4 counts <100 cells/mm3 from eight African HIV clinics were randomized 1:1 to receive standard triple-ART, +/−12 weeks of raltegravir, and followed for 48 weeks. From June 2013 to April 2015, 1805 persons enrolled in the study (53% male; median age, 36; median CD4 count, 37 cells/mm3; median HIV level, 249,770 copies/mL).

Raltegravir was well tolerated. The raltegravir group, as expected, had a higher rate of viral suppression at 12 weeks than the standard-ART group (71.9% vs. 51.7%). At 24 weeks the mortality rate did not differ between treatment groups (10.9% with raltegravir vs. 10.2% with standard ART). No difference was seen in mortality rate at 48 weeks (adjusted hazard ratio, 0.98) or in events compatible with IRIS (9.9% vs. 9.5%). The authors conclude that intensification of initial ART with raltegravir for this population is not warranted.


These data provide further confirmation that intensification of initial ART for the treatment of advanced HIV disease generally is not warranted. However, they also support consideration of use of integrase inhibitors as a component of standard ART for advanced disease due to demonstrated potency and tolerability without evidence of additional risk for IRIS.

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