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Abstract
TMC114/r is well tolerated by treatment-experienced patients in power 1, 2 and 3: integrated clinical safety analysis
J. Valdez Madruga1, A. Lafeuillade2, G. Beatty3, S. Spinosa-Guzman4, M. El Malt4, E. Lefebvre5
Background: The PI TMC114, co-administered with low-dose ritonavir (TMC114/r), demonstrated significantly better efficacy than control PIs (CPIs) among treatment-experienced patients in the controlled POWER 1/2 studies. Similar efficacy was seen in an analysis of a large, open-label patient group (POWER 3). This pooled analysis assesses the clinical safety of the recommended treatment-experienced dose, TMC114/r 600/100mg bid, in POWER 1, 2 and 3.
Methods: Patients were PI-, NRTI- and NNRTI-experienced, with ³1 primary PI mutation at baseline. AEs were evaluated in all POWER 1–3 patients using TMC114/r 600/100mg bid in their initial regimen (de novo; n=458) and POWER 1 and 2 patients using CPIs (n=124).
Results: The majority of AEs were grade 1–2 in severity. Frequency of discontinuations and the most common AEs are shown in the tables. The frequency of serious AEs (SAEs) was 15% for TMC114/r versus 14% for CPI; no individual SAE occurred in >1% of patients. Eleven TMC114/r patients died with no case considered at least possibly related to TMC114/r treatment.
| | POWER 1–3
TMC114/r 600/100mg bid de novo
(n=458)
| POWER 1 and 2
CPIs
(n=124)
| | All discontinuations (%) | 11 | 81 | | Due to AE (%) | 4 | 5 | | Due to virologic failure (%) | 3 | 67 |
| Diarrhea (%) | 16 | 28 | | Nausea (%) | 12 | 13 | | Nasopharyngitis (%) | 12 | 11 | | Headache (%) | 11 | 20 |
| Diarrhea (%) | 3 | 3 | | Vomiting (%) | 2 | 2 | | Headache (%) | 2 | 2 |
Conclusions: TMC114/r is generally well tolerated by treatment-experienced patients. The incidence of diarrhea with TMC114/r was lower than with CPIs. TMC114/r is expected to provide a valuable HIV therapy option.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
TUPE0062
Suggested Citation
"J.ValdezMadruga, et al.
TMC114/r is well tolerated by treatment-experienced patients in power 1, 2 and 3: integrated clinical safety analysis.
:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
TUPE0062"
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