Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data

Cost Effectiveness and Resource Allocation

Richard H Haubrich³  Menaka Bhor²  Sharon A Riddler¹  Kevin W Garren²  Robert W Baran²  Birgitta Dietz⁴  Kit N Simpson⁵ 

[1] University of Pittsburgh, Pittsburgh, PA, USA;Abbott Laboratories, Abbott Park, IL, USA;University of California, San Diego, CA, USA;Abbott GmbH & Co KG, Ludwigshafen, Germany;Medical University of South Carolina, SC, USA

关键词: economics;    Markov model;    AIDS;    HIV;    antiretroviral therapy;    efavirenz;    lopinavir/ritonavir;   

Others  :  812204
DOI  :  10.1186/1478-7547-9-5

 received in 2010-05-27, accepted in 2011-05-08,  发布年份 2011

【 摘 要 】

Background

This study examines the cost and consequences of initiating an ARV regimen including Lopinavir/ritonavir (LPV/r) or Efavirenz (EFV), using data from a recent clinical trial in a previously published model of HIV-disease.

Methods

We populated the Markov model of HIV-disease with data from ACTG 5142 study to estimate the economic outcomes of starting ARV therapy with a PI-containing regimen as compared to an NNRTI-containing regimen, given their virologic and immunologic efficacy and effects on cholesterol and lipoatrophy. CNS toxicities and GI tolerability were not included in the model because of their transient nature or low cost remedies, and therefore lack of economic impact. CD4+ T-cell counts and the HIV-1 RNA (viral load) values from the study were used to assign a specific health state (HS) to each patient for each quarter year. The resulting frequencies used as "raw" data directly into the model obviate the reliance on statistical tests, and allow the model to reflect actual patient behavior in the clinical trial. An HS just below the last observed HS was used to replace a missing value.

Results

The modeled estimates (undiscounted) for the LPV/r-based regimen resulted in 1.41 quality-adjusted life months (QALMs) gained over a lifetime compared to the EFV-based regimen. The LPV/r-based regimen incurred $7,458 (1.8%) greater cost over a lifetime due to differences in drug costs and survival. The incremental cost effectiveness ratio using the discounted cost and QALYs was $88,829/QALY. Most of the higher costs accrue before the 7th year of treatment and were offset by subsequent savings. The estimates are highly sensitive to the effect of lipoatrophy on Health-related Quality of Life (HRQOL), but not to the effect of cholesterol levels.

Conclusions

The cost effectiveness of ARV regimens may be strongly affected by enduring AEs, such as lipoatrophy. It is important to consider specific AE effects from all drugs in a regimen when ARVs are compared.

Trial registration

(ClinicalTrials.gov number, NCT00050895http://[ClinicalTrials.gov] webcite).

【 授权许可】

   
2011 Simpson et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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