|
15th Annual Conference of the British HIV Association1-3 April 2009, Liverpool, UK |
IMPACT OF BASELINE (BL) ANTIRETROVIRAL RESISTANCE STATUS ON EFFICACY OUTCOMES AMONG PATIENTS RECEIVING MARAVIROC (MVC) PLUS OPTIMIZED BACKGROUND THERAPY (OBT) IN THE MOTIVATE 1 AND 2 STUDIES
HIV Med 2009 Apr 1-3 (Suppl 1);15:7 (abstract no. O22)
A Teague1, M Nelson1, M Fisher2, J Gonzalez-Garcia3 and J Rockstroh4
1Chelsea and Westminster Hospital, London, UK, 2Brighton & Sussex University Hospitals, Brighton, UK, 3Hospital Universitario La Paz, Madrid, Spain, 4University of Bonn, Bonn, Germany
BACKGROUND: MOTIVATE 1&2 enrolled treatment-experienced (TE) patients with triple drug-class experience and/or triple-class resistance.
METHODS: Efficacy endpoints were evaluated post hoc among patients in the MVC BID and placebo (PBO) arms categorized by BL resistance testing as either triple-class-resistant (TCR–resistance to NRTI, NNRTI and PI classes) or not triple-class-resistant (nTCR), and among patients with ≥2 active OBT drugs (wOBTSS ≥2).1
RESULTS: At screening, TCR patients had a median of 11, 2 and 7 mutations conferring reduced susceptibility to PI, NNRTI and NRTI, respectively, versus 4, 0 and 4 for nTCR patients (P<0.001). Efficacy at 48 weeks in patients receiving MVC+OBT is shown below.
|
|
|||
| Parameter | TCR (N=261) | nTCR (N=165) | Difference/OR (95% CI) |
|
|
|||
| Mean change from BL in VL, log10 copies/mL | -1.74 | -2.05 | Difference: 0.31 (0.05, 0.58) |
| VL <50 copies/mL, % | 42.9 | 49.7 | Odds ratio: 0.78 (0.51, 1.19) |
| Mean change from BL in CD4 count, cells/mm3 | 110 (n=257) | 150 (n=161) | Difference: -40 (-62, -18) |
|
|
|||
Even when the OBT included ≥2 other active agents (by wOBTSS), mean CD4 count increases were higher with MVC in nTCR patients versus the TCR subgroup (+184 versus +125 cells/mm3; difference: -59 [95% CI: 110, -8]) despite virologic response rates that were not significantly different. Similarly, in patients with <50 copies/mL at Week 48, CD4 count increases were higher with MVC in the nTCR versus the TCR subgroup (192 versus 136 cells/mm3; difference: -56 [95% CI: -93, -19]). These differences were not observed in the PBO+OBT arm.
CONCLUSIONS: These data suggest MVC use may be more beneficial in TE patients with R5 virus who do not have triple class-resistant virus than in more heavily treatment-experienced patients.
1Valdez et al. 48th ICAAC/IDSA 2008, abstract H-1221.
2009-04-01
O22
Copyright © 2009 - British HIV Association (BHIVA) Reproduction of this abstract (other than one copy for personal reference) must be cleared through the BHIVA Organising Secretariat 1 Mountview Court, 310 Friern Barnet Lane, London N20 0LD