6th IAS Conference On HIV Pathogenesis, Treatment and Prevention


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TUAB0106 - Oral Abstract Session

Efficacy of maraviroc (MVC) administered once daily (QD) or twice daily (BID) with boosted protease inhibitors (bPIs) to treatment-experienced patients

Presented by David Hardy (United States).

S. Taylor1, J. Arribas2, C.-F. Perno3, R. Burnside4, L. McFadyen5, D. Hardy6, H.-J. Stellbrink7, D.A. Cooper8, J.-M. Molina9, E. van der Ryst5, J. Heera4, H. Valdez10

1Birmingham Heartlands Hospital, Birmingham, United Kingdom, 2Hospital La Paz, Madrid, Spain, 3University of Rome, Tor Vergata, Italy, 4Pfizer, Inc., New London, CT, United States, 5Pfizer, Sandwich, Kent, United Kingdom, 6Cedars-Sinai Medical Center/Geffen School of Medicine-UCLA, Los Angeles, CA, United States, 7ICH Study Center, Hamburg, Germany, 8University of New South Wales and St Vincent's Hospital, Sydney, Australia, 9Assistance Publique-Hopitaux de Paris, Paris, France, 10Pfizer, Inc., New York, NY, United States

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.

 Percent patients achieving VL <50 copies/mL at 48-weeks
Patient Group (MVC dose)MVC QD % (n/N)MVC BID % (n/N)Placebo % (n/N)
All patients (150 mg or 300 mg)*45.4 (152/335)48.2 (158/328)16.3 (29/178)
Any bPI (except bFPV and bTPV) (150 mg)*45.5 (85/187)47.7 (84/176)16.5 (14/85)
Baseline VL >=5 log38.5 (30/78)39.0 (30/77)14.3 (6/42)
Baseline CD4 <5017.2 (5/29)18.5 (5/27)5.0 (1/20)
wOBTSS >=159.7 (71/119)58.1 (68/117)26.3 (15/57)
bFPV (150 mg)*38.0 (19/50)42.9 (24/56)16.3 (7/43)
wOBTSS: weighted optimized background therapy susceptibility score. * MVC doses were adjusted to 150 mg QD or BID when co-administered with a PI (except TPV/r) and/or delavirdine.
[Table 1]

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.

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