Safety and immunovirological activity of once daily maraviroc (MVC) in combination with ritonavir-boosted atazanavir (ATV/r) compared to emtricitabine 200mg/tenofovir 300mg QD (TDF/FTC) + ATV/r in treatment-naïve patients infected with CCR5-tropic HIV-1 (Study A4001078): A week 24 planned interim analysis
A. Mills1, D. Mildvan2, D. Podzamczer3, G. Fätkenheuer4, M. Leal5, S. Than6, S. Valluri6, C. Craig7, J. Heera6, S. Portsmouth6
1Los Angeles, CA, Los Angeles, United States, 2Beth Israel Medical Center Division of Infectious Diseases, New York, United States, 3HIV Unit, Infectious Disease Service, Hospital Unversitari de Bellvitge, Barcelona, Spain, 4Universitaet Koeln, Koeln, Germany, 5Laboratory of Immunovirology, Biomedicine Institute of Seville (IBIS), Infectious Diseases Service, Virgen del Rocio University Hospital, Sevilla, Spain, 6Pfizer Inc, New York, United States, 7Pfizer Global Research and Development, Sandwich, United Kingdom
Background: Nucleoside sparing regimens avoid mitochondrial, bone, renal and other toxicities. MVC is a CCR5 antagonist approved for twice-daily use in CCR5-tropic (R5) HIV-1-infected patients. Since most protease inhibitors increase MVC concentrations, a once-daily nucleoside sparing regimen of MVC + ATV/r 150mg is under investigation in this 48 week, open-label pilot study.
Methods: 121 R5 HIV-1-infected treatment-naïve subjects (CD4+ counts ≥100 cells/µL) were randomized to receive ATV/r with either MVC 150mg QD or TDF/FTC.
Results: Baseline characteristics were comparable. Outcomes were comparable between the two groups. There were no deaths, 4 (6.7%) SAE's with MVC vs 8 (13.1%) with TDF/FTC. No SAEs were considered to be MVC related. Five MVC and 4 TDF/FTC patients discontinued by week 24. There was one malignancy and one category C event in each arm. Sixteen MVC and 8 TDF/FTC grade 3 or 4 AEs were related to hyperbilirubinemia. Forty-nine MVC and 44 TDF/FTC patients had indirect bilirubin levels >1.5 xULN on study.
Conclusion: These results suggest that dual therapy with a simplified once-daily regimen of MVC 150mg with ATV/r is active and well-tolerated. A formal noninferiority comparison between these regimens in a larger, appropriately-powered double-blinded study is warranted.
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