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  • Open Access

96 weeks pharmacoeconomic outcome of lopinavir/r monotherapy as maintenance strategy in HIV+ patients with suppressed viral load. OK04-PharmECO analysis

  • 1,
  • 2,
  • 3,
  • 3,
  • 4,
  • 5 and
  • 5
Journal of the International AIDS Society200811 (Suppl 1) :P308

https://doi.org/10.1186/1758-2652-11-S1-P308

  • Published:

Keywords

  • Viral Load
  • Nucleoside
  • Therapeutic Efficacy
  • Virological Failure
  • Probabilistic Sensitivity Analysis

Purpose of the study

The OK04 clinical trial has shown, at 96 weeks, that lopinavir/ritonavir (LPV/r) monotherapy (MT) with re-introduction of nucleosides as needed was non-inferior to continuation of triple therapy (T) [1]. A pharmacoeconomic analysis from the perspective of the Spanish Healthcare System was performed to estimate cost-effectiveness of both study arms.

Methods

OK04 methodology, baseline characteristics, and 96-week efficacy/safety related outcomes showing non-inferiority have been described elsewhere [1]. Briefly, 198 patients were randomised 1:1 to the MT (n = 100) or T (n = 98). Virological efficacy was defined as absence of virological failure, i.e. two consecutive plasma HIV-RNA concentrations >500 copies/mL through 96 weeks from the start of the study without changes on randomized treatment. Therapeutic efficacy included the maintenance of undetectable viral load (<50 cop/mL) with the re-induction of nucleosides in MT arm (if necessary). Data on resource utilization related with follow-up, reported adverse events (AE) management, concomitant medications and extra-procedures were collected. Direct costs were computed from resource utilization in Spanish 2007 euros. Incremental cost-effectiveness ratio of MT vs. T (MT-T) was calculated. An annual 3% discount rate was applied both for costs and results. Sensitivity analyses were performed, including a Montecarlo simulation of 10,000 samples.

Summary of results

After 96 weeks, therapeutic efficacy was 84.5% (MT) vs. 76.8% (T) (MT-T = 7.6%). MT showed better results vs. T in time on therapeutic efficacy (incremental time mean, 3.7 weeks-patient), time on virological efficacy (incremental time mean, 2.3 weeks-patient), and the proportion of AEs related with study drug drop-outs (differential %, -8.0%). No difference was found on number of future treatment options. Differential costs were -5,563 €/patient, mainly due to antiretroviral-related differential drug acquistion costs. Economic analysis showed MT dominance in cost/therapeutic efficacy, cost/patient-week on therapeutic and virological efficacy, and cost/avoided drop-out related to the study drug. Probabilistic sensitivity analysis showed 93.65% scenarios where MT therapeutic efficacy was cost effective (77.5% dominant).

Conclusion

LPV/r MT (including re-introduction of nucleosides as needed) is an efficient option for maintenance therapy in HIV-infected patients when compared with LPV/r T. This may become a breakthrough treatment decision criterion in current health saving costs environment.

Authors’ Affiliations

(1)
Hospital La Paz, Madrid, Spain
(2)
Hospital Doce de Octubre, Madrid, Spain
(3)
TAISS, Madrid, Spain
(4)
Abbott Labs, Chicago, USA
(5)
Abbott Laboratories, SA, Madrid, Spain

References

  1. Arribas JR, et al: PS3/1. 11th EACS, Madrid, October 2007; PS3/1.Google Scholar

Copyright

© Arribas et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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