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CADIRIS: Maraviroc ineffective at IRIS prevention in patients with low CD4 count
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ATLANTA — Data from a late breaker presented here indicate that maraviroc was safe and well tolerated in patients with HIV who initiated antiretroviral therapy with low CD4 counts. However, the drug did not prevent immune reconstitution inflammatory syndrome in these patients.
The CADIRIS study was a prospective, multicenter, two-arm, randomized 1:1 placebo-controlled clinical trial that assessed the addition of maraviroc (Selzentry, ViiV Healthcare) 600 mg twice daily to standard ART (efavirenz/tenofovir/emtricitabine [Atripla, Gilead Sciences]) for the prevention of or reduction in the severity of immune reconstitution inflammatory syndrome (IRIS) in patients (n=276) treated in South Africa and Mexico between December 2009 and February 2011. Primary outcome measure was development of IRIS within 24 weeks after ART initiation.
The researchers hypothesized that CCR5 blockade would block the post-ART distribution of effector T cells, which would then decrease the risk for clinical IRIS.
At least one IRIS event developed in 23.6% of those assigned maraviroc and in 22.8% of those assigned placebo. Severe IRIS events occurred in 5.5% and 6.6% of patients, respectively (P=.614). No differences were observed in time to IRIS events between either group (P=.743).
Change in mean CD4 count was 118 cells/mcL for the maraviroc group and 99 cells/mcL for the placebo group at week 12 (P=.01) and 130 cells/mcL for the maraviroc group and 118 cells/mcL for the placebo group at week 24 (P=.20).
By week 24, the proportion of patients with HIV RNA levels <50 copies/mL was 75% among those assigned maraviroc and 85% among those assigned placebo. The proportion of those with HIV RNA levels <400 copies/mL was 93.7% for the maraviroc group and 96.7% for the placebo group (P=.26). Mortality occurred in 2% in the maraviroc arm and 1.4% in the placebo arm.
Juan Sierra-Madero
“CCR5 inhibitors are not effective at preventing inflammatory phenomena associated with HAART initiation,” Juan Sierra-Madero, MD, of the National Institute of Medical Sciences and Nutrition Salvador Zubiran in Mexico, told Infectious Disease News. “There are no clinical implications, so far, derived from this data. This class of drugs is not currently used for this purpose, and our data support no change in practice.”
For more information:
Sierra-Madero J. #182LB. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6; Atlanta.
Disclosure: Sierra-Madero reports no relevant financial disclosures.