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Efficacy of maraviroc administered once-daily or twice-daily with boosted protease inhibitors to treatment-experienced patients
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Reported by Jules Levin
6th IAS Rome Italy July 17-20 2011
S Taylor,1 J Arribas,2 C-F Perno,3 R Burnside,4 L McFadyen,5 D Hardy,6 H-J Stellbrink,7 DA Cooper,8 J-M Molina,9 E van der Ryst,5 J Heera,4 H Valdez10
1 Birmingham Heartlands Hospital, Birmingham, UK; 2 Hospital La Paz, Madrid, Spain; 3 University of Rome, Tor Vergata, Italy; 4 Pfizer Inc., Groton, CT, USA;
5 Pfizer Global Research and Development, Sandwich, Kent, UK; 6 Cedars-Sinai Medical Center/Geffen School of Medicine-UCLA, Los Angeles, CA, USA;
7 ICH Study Center, Hamburg, Germany; 8 University of New South Wales and St VincentÕs Hospital, Sydney, Australia;
9 Assistance Publique-Hopitaux de Paris, Paris, France;
10 Pfizer Inc., New York, NY, USA
Objective
¥ To ascertain that the efficacy of MVC in combination with a bPI (except TPV/r) is not compromised by less-frequent administration, particularly in key subgroups of patients.
Abstract
Background: bPIs (except tipranavir/r) increase MVC concentrations. MVC 150 mg QD administered with bPIs (300 mg total daily dose with fosamprenavir/r) achieves similar plasma AUC as MVC 300 mg BID without bPIs.
Methods: MOTIVATE trial patients received MVC QD or BID plus optimized background therapy*. Participants with R5 virus (ESTA) were included (n=841). We predicted that MVC would be effective at 150 mg QD with any bPI (except tipranavir and fosamprenavir [any bPI]) and 300 mg QD with fosamprenavir/r. We compared the percentage of patients achieving viral load (VL) ,50 copies/mL (48-weeks) among patients who received any bPI and MVC 150 mg QD and BID, and bFPV and MVC total daily dose of 300 mg (bold text, table).
Results: Baseline characteristics between groups were similar.
Multivariate analysis showed that MVC administration, higher baseline CD4 count,
greater wOBTss, not having a MVC level below quantification (but not MVC
concentration) were important factors predicting treatment success.
Conclusion: Combined with a bPI (except tipranavir/r), MVC QD (300 mg with bFPV,
150 mg with other bPIs) appears to be as effective as BID, even in patients with
high baseline VL or low CD4 count. A similar proportion of patients achieved
VL ,50 copies/mL when MVC was dosed QD or BID with >1 other fully active drug.
References
1. Fatkenheuer G, et al. Nat Med 2005; 11: 1170-1172.
2. Weatherley B, et al. Poster 17a presented at the 9th International Workshop on Clinical Pharmacology of HIV Therapy,
New Orleans, LA, 7-9 April 2008.
3. Gulick RM, et al. N Engl J Med 2008; 359: 1429-1441.
4. Hardy WD, et al. J Acquir Immune Defic Syndr 2010. Epub ahead of print.
5. Portsmouth SD, et al. HIV Med 2005; 6: 185-190.
6. Raboud J, et al. AIDS Behav 2010. Epub ahead of print.
7. Schapiro JM, et al. Antivir Ther 2011; 16: 395-404.
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