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Abstract
Responses to IL-2 in Subjects that Received Potent Antiretroviral Therapy (ART) Alone for 18 Months as Compared to those Treated with ART plus IL-2. (ACTG 5051)
Pollard R.1, Landay A.2, Aga E.3, Bosch R.3, Fox L.4, Mitsuyasu R.5
Introduction: A5051 was a continuation of A328. Protease naïve’s with 50-350 CD4 in A328 had ART for 12 weeks and if below 5,000 HIV RNA/ml received ART (Group I) or IL-2 plus ART (Group II) for 16 months. In A5051, Group I received IL-2 plus ART at 4.5mu BID 5 days every 8 weeks, and Group II subjects with greater than 25% increase in CD4 continued for 18 months.
Methods: Group I received 3 IL-2 cycles and if their CD4 counts were above 500, intervals were lengthened. Group II patients received IL-2 when their counts fell below 500. Cell counts and HIV RNA were done every 8 weeks. Side effects of IL-2 were monitored. Statistical analyses included Wilcoxon ranksum, Fisher’s exact and logrank tests.
Results: 80 subjects were in A5051, 27 Group I and 53 from Group II (approximately 50% of the A328 subjects). Baseline differences between the two was in median CD4 (466 Group I and 832 Group II p <0.001). All were on at least 3 antiretrovirals. While not significant (p=0.13), 7/27 (26%) Group I patients discontinued IL-2 vs. 7/53 (13%) Group II. There were no differences in routine laboratory measurements or symptoms. Response to IL-2 was defined as a 50% increase in CD4 (12/22 (55%) Group I patients at 48 weeks versus 2/50 (4%) of Group II, p < 0.001). At 72 weeks 12/20 (60%) in Group I versus 4/47 (9%) Group II (p < 0.001). Group I increased at week 48 to 686 CD4 versus Group II, 883 CD4. Week 72, Group I had 804 CD4 and Group II 847.
Conclusions: Patients receiving ART alone for 18 months responded similarly to IL-2 as patients on 12 weeks of ART. Those who previously responded to IL-2 maintained CD4 cells for 18 months. IL-2 was relatively well tolerated.
The 3rd IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
WePe12.8C01
Suggested Citation
"PollardR., et al.
Responses to IL-2 in Subjects that Received Potent Antiretroviral Therapy (ART) Alone for 18 Months as Compared to those Treated with ART plus IL-2. (ACTG 5051).
Poster Exhibition:
The 3rd IAS Conference on HIV Pathogenesis and Treatment:
Abstract no.
WePe12.8C01"
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