Medical Advocates for Social Justice
Conference Abstract
from the
2nd IAS Conference on HIV and Pathogenesis
Paris, France

July 14-17, 2003

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Objective:
To evaluate the virological, immunological and clinical response of the boosted double PI regimen combination of LPV/r plus  SQV without reverse transcriptase inhibitors (RTI) in patients who have no RTI options available due to resistance or systemic toxicity.

Methods:
Prospective cohort study of 121 heavily pre-treated patients in the Frankfurt HIV Cohort who were experiencing treatment failure with an RTI-containing regimen. Genotype testing was performed to assess resistance. The patients were switched to a double PI salvage regimen of LPV/r 400/100 mg plus SQV 1000 mg BID without the addition of RTIs or any other antiretroviral therapy. Intensive pharmacokinetic (PK) assessment was performed under steady-state conditions after a minimum of 14 days on the regimen to rule out any unfavourable drug interactions between the PIs. Statistical analysis of plasma exposure was performed using a non-compartmental approach.

Results:
64 patients (13 female) were available for week 24 analysis. Median baseline characteristics include: viral load of 5.2 log10 copies/ml, 168 CD4 cells/mm3, age 41 yrs, 6.7 years ART experience, and a previous exposure of 10 drugs. At week 24, 52 (81%) patients were still on therapy. Median viral load at week 24 (n=42) was 2.1 log10 (range 1. –6.0 log10) and median CD4 count was 299 cells/mm3 (range 1–750). Plasma concentration levels of LPV and SQV were lower in non-responders (AUCss –22%, Cmin –32%; AUCss –47%, Cmin –50%, respectively) compared to responders. Nonresponders also had lower pre-dose levels than responders: SQV 244 vs 903 ng/ml; LPV 3790 vs 4945 ng/ml. Other factors associated with response were higher CD4 count at baseline (196 cells/mm3 vs 66 for non-responders), fewer PI mutations in the last failing regimen (2 vs  for non-responders), less prior PI experience. Conclusion: LPV/r +SQV therapy may be a potent option as salvage therapy for patients with RTI resistance or toxicity but may not be suitable for patients with heavy PI resistance and very low CD4 count.

The LOPSAQ Study: 24 Week Analysis of the Double Protease Inhibitor (PI) Salvage Therapy Regimen Containing Lopinavir (LPV/r) plus Saquinavir (SQV) without any additional Antiretroviral (ART) Therapy
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