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Efficacy and Safety (malignancies) of Maraviroc in Treatment-Experienced (TE) Patients Infected with R5 HIV-1: 96-week Combined Analysis of the MOTIVATE 1 & 2 Studies
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Reported by Jules Levin
9th International Congress on Drug Therapy in HIV Infection
Glasgow, UK, November 9-13, 2008
WD Hardy1, R Gulick2, H Mayer3, G Fätkenheuer4, M Nelson5, J Heera3, N Rajicic6, J Goodrich3
1 Cedars-Sinai Medical Center/Geffen School of Medicine, UCLA, Los Angeles, CA, USA
2 Weill Medical College of Cornell University, New York, CA, USA
3 Pfizer Global Research and Development, New London, CT, USA
4 University of Cologne, Köln, Germany
5 Chelsea & Westminster Hospital, London, UK
6 Pfizer Inc., New York, NY, USA
MOTIVATE 1 & 2 Week 96: AUTHOR SUMMARY
Efficacy Analysis
Maraviroc + OBT results in durable viral suppression through 96 weeks in treatment-experienced patients with R5 HIV-1
-- 87% of patients in the BID arm who were fully suppressed at Week 48 remained suppressed at Week 96
Safety Analysis
Pooled analyses revealed no new or unique safety signals between Week 48 and end of blinded therapy
-- Category C events, malignancies, and LFT abnormalities occurred with similar frequency among treatment groups when not adjusted for the longer duration of exposure in the maraviroc groups
-- The incidence of these events decreased between Week 48 and end of blinded therapy
After adjusting for exposure, the incidence of Category C events and malignancies was lower in the maraviroc groups compared to placebo
BACKGROUND
Maraviroc (Selzentry/Celsentri; MVC) is an approved CCR5 antagonist with antiviral activity against CCR5-tropic (R5) HIV-11
The efficacy and safety of MVC in treatment-experienced patients with R5 virus have been assessed in two randomized, double-blind, placebo-controlled Phase 3 studies: MOTIVATE 1 (USA, Canada) and MOTIVATE 2 (Europe, Australia, USA)2-7
In both studies, MVC (QD or BID) + optimized background therapy (OBT) demonstrated significantly greater virologic and immunologic efficacy and a similar safety profile compared to placebo + OBT in the Week 48 primary analysis2,3,6,7
Since the study design, inclusion/exclusion criteria, conduct, monitoring, and statistical analyses of MOTIVATE 1 and 2 were identical, pooling of data from the two studies was appropriate, resulting in larger sample sizes for subgroup analyses
We present the results of a pooled data analysis at Week 96 from the two MOTIVATE studies
1. Dorr P, et al. Antimicrob Agents Chemother 2005; 49:4721-4732
2. Lalezari J, et al. 47th ICAAC 2007; Presentation H-718a
3. Fätkenheuer G, et al. 11th EACS 2007; Presentation PS3/5
4. Lalezari J, et al. 14th CROI 2007; Presentation 104bLB
5. Nelson M, et al. 14th CROI 2007; Presentation 104aLB
6. Gulick RM, et al. N Engl J Med 2008; 359:1429-1441.
7. Fätkenheuer G, et al. N Engl J Med 2008; 359:1442-1455.
RTI, respiratory tract infection
If the same patient in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence is taken. Event counts are adjusted to 100 years of patient exposure. Includes data up to 7 days after last dose of study drug.
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