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Efficacy and Safety of Maraviroc in Antiretroviral-Experienced Patients Infected With CCR5-Tropic HIV-1: 48-Week Results of MOTIVATE 1
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Reported by Jules Levin
ICAAC Sept 17-20, 2007
J Lalezari1, J Goodrich2 , E DeJesus3, R Gulick4, H Lampiris5, M Saag6, N Bellos7, J Nadler8, P Tebas9, B Trottier10, M Wohlfeiler11, C Ridgeway12, M McHale12, E van der Ryst12, H Mayer2, on behalf of the MOTIVATE 1 Study Team
1Quest Clinical Research, UCSF, San Francisco, CA, USA
2Pfizer Global Research and Development, New London, CT, USA
3Orlando Immunology Center, Orlando, FL, USA
4Weill Medical College of Cornell University, New York, NY, USA
5San Francisco Veterans Affairs Medical Center, UCSF, San Francisco, CA, US
6University of Alabama at Birmingham, Birmingham, AL, USA
7Southwest Infectious Disease Associates, Dallas, TX, USA
8University of South Florida, Tampa, FL, USA
9University of Pennsylvania, Philadelphia, PA, USA
10Clinique Medicale L'Actuel, Montreal, QC, CANADA
11Wohlfeiler, Piperato & Associates, North Miami Beach, FL, USA
12Pfizer Global Research and Development, Sandwich, UK
MOTIVATE 1: Summary of 48-Week Primary Analysis
Maraviroc (BID or QD) + OBT provided significantly greater virologic suppression rates and increases in CD4+ count compared to OBT alone at 48 weeks in this treatment-experienced population
No new or unique safety findings emerged
--Adverse events, serious adverse events, and lab abnormalities (including grade 3/4 transaminase elevations) occurred with similar frequency between treatment groups
--Category C (AIDS-defining events) were balanced across treatment groups
These results demonstrate that treatment with maraviroc + OBT provides sustained antiretroviral efficacy and tolerability in treatment-experienced patients
BACKGROUND
MOTIVATE 1 is one of two randomized, double-blind, placebo-controlled,
Phase 3 studies investigating the safety and efficacy of the CCR5 antagonist maraviroc, in treatment-experienced patients with R5 HIV-1
In a planned interim analysis at 24 weeks1, maraviroc (QD and BID)
+ OBT vs OBT alone demonstrated
--significantly greater virologic suppression rates
--significantly greater increases in CD4+ count
--no clinically relevant differences in safety profile
The MOTIVATE 1 primary efficacy endpoint is the change from baseline in HIV-1 RNA at 48 weeks
Patient eligibility criteria:
--R5 HIV-1 infection
--HIV-1 RNA ≥5,000 copies/mL
--Stable pre-study ARV regimen, or no ARVs for ≥ 4 weeks
-- Resistance to and/or ≥ 6 months' experience with ≥ one ARV
from three classes (≥ two for PIs)
Patients stratified by:
--Enfuvirtide use in OBT
--HIV-1 RNA < and ≥100,000 copies/mL at screening
Percentage of Patients with Undetectable HIV-1 RNA
Includes all patients who received at least one dose of study medication
Number of patients remaining on study treatment at Week 48:
OBT alone, 27 (30%); MVC QD + OBT, 109 (60%); MVC BID + OBT, 127 (66%)
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