TUAB0103 - Oral Abstract Session
48-week results of a dual-therapy regimen of once-daily maraviroc (MVC) 150 mg in combination with ritonavir-boosted atazanavir (ATV/r) compared to emtricitabine/tenofovir (FTC/TDF) + ATV/r in treatment-naïve (TN) patients infected with CCR5-tropic H
Presented by Anthony Mills (United States).
S. Portsmouth1, C. Craig2, A. Mills3, D. Mildvan4, D. Podzamczer5, G. Fätkenheuer6, M. Leal7, H. Valdez1, S.R. Valluri1, J. Heera1
1Pfizer, Inc., New York, United States, 2Pfizer, Sandwich, Kent, United Kingdom, 3UCLA, Los Angeles, United States, 4Beth Israel Medical Center, Division of Infectious Diseases, New York, United States, 5Hospital Universitari de Bellvitge, HIV Unit, Infectious Disease Service, Barcelona, Spain, 6Universitaet Koeln, Koeln, Germany, 7Virgen del Rocio University Hospital, Laboratory of Immunovirology, Biomedicine Institute of Seville (IBIS), Infectious Disease Service, Seville, Spain
Background: MVC is a CCR5 antagonist approved for twice-daily use in CCR5-tropic (R5) HIV-1-infected patients. This Phase 2b, randomized, open-label pilot study evaluated this dual-therapy, nucleoside-sparing, once-daily (QD), 150 mg MVC-containing regimen in TN patients.
Methods: 121 R5 HIV-1-infected patients (CD4+ count ≥100 cells/µL) were randomized to ATV/r (300/100 mg) in combination with either MVC 150 mg QD (n=60) or FTC/TDF 200/300 mg QD (n=61). The primary endpoint was the proportion with HIV-1 RNA < 50 copies/mL at Week 48.
Results: The difference between the arms in the proportion of patients with HIV-1 RNA < 50 and < 400 copies/mL (MVC: 74.6% < 50 [44/59], 89.8% < 400 [53/59]; FTC/TDF: 83.6% < 50 [51/61], 86.9% < 400 [53/61]) was similar to that at Week 24. Mean change from baseline in CD4+ count at Week 48 was comparable between treatment arms (MVC: +215 cells/mm3; FTC/TDF: +226 cells/mm3). At Week 48 seven patients had discontinued therapy in each arm; there were no deaths. Protocol-defined treatment failure occurred in two patients in each arm. Creatinine clearance was stable in the MVC arm and decreased in the FTC/TDF arm (median change from baseline, -12 mL/min). 10 patients in the MVC arm versus 11 in the FTC/TDF arm had serious adverse events (AEs), none of which were related to assigned study drug. More MVC than FTC/TDF recipients had treatment-related grade 3 or 4 AEs (18 vs 11) and these were mostly due to hyperbilirubinemia. Three individuals in each arm had plasma HIV-1 RNA >500 copies/mL at failure or study discontinuation; virologic analyses detected no resistance, change in tropism, or loss of susceptibility relevant to treatment in either arm.
Conclusion: MVC 150 mg QD + ATV/r resulted in a high proportion of patients achieving viral suppression at Week 48. No resistance or loss of susceptibility to study drugs was observed.
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