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Low Nevirapine Plasma Concentrations Predict Virological Failure in an Unselected HIV-1-Infected Population

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Abstract

Objective

To assess the relationship between plasma nevirapine concentrations and plasma HIV-1 RNA response in HIV-1-infected patients.

Design

An observational cohort analysis.

Methods

Plasma samples were obtained on a routine basis from 189 patients receiving nevirapine 200mg twice daily, and plasma nevirapine concentrations were measured with reversed phase high performance liquid chromatography. Patients were divided into two groups based on plasma nevirapine concentrations below (and equal to) or above 3 mg/L. The association between steady-state nevirapine concentrations and plasma HIV-1 RNA was determined by multi-variate analysis.

Results

Out of 189 patients, 13 (7%) had low nevirapine plasma concentrations and 176 patients had concentrations above 3 mg/L. In total, 22 (12%) patients showed virological failure and 8 patients (4%) discontinued nevirapine because of adverse effects. The risk of failure in patients with nevirapine plasma concentrations ≤3mg/L was increased (relative risk 5.0, 95% CI 1.8–13.7). Rashes and liver enzyme elevations each occurred in 8% of patients.

Conclusion

Low nevirapine drug concentrations are predictive of virological failure.

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Acknowledgements

We are grateful to Professor J.H.P. Wilson for his critical comments. There was no source of funding or conflict of interest directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Internal Medicine, University Hospital Rotterdam, Dijkzigt, Dr Molewater-plein 40 Rotterdam, 3015 GD, The Netherlands

    Theodora E. M. S. de Vries-Sluijs, Dennis Arts & Marchina E. van der Ende

  2. Department of Epidemiology, Erasmus University Rotterdam, Rotterdam, The Netherlands

    Jeanne P. Dieleman

  3. Department of Pharmacy and Pharmacology, Slotervaart Hospital, Amsterdam, The Netherlands

    Alwin D. R. Huitema & Jos H. Beijnen

  4. Department of Virology, University Hospital Rotterdam, Dijkzigt, Rotterdam, The Netherlands

    Martin Schutten

Authors
  1. Theodora E. M. S. de Vries-Sluijs
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  2. Jeanne P. Dieleman
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  3. Dennis Arts
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  4. Alwin D. R. Huitema
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  5. Jos H. Beijnen
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  6. Martin Schutten
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  7. Marchina E. van der Ende
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Correspondence to Marchina E. van der Ende.

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de Vries-Sluijs, T.E.M.S., Dieleman, J.P., Arts, D. et al. Low Nevirapine Plasma Concentrations Predict Virological Failure in an Unselected HIV-1-Infected Population. Clin Pharmacokinet 42, 599–605 (2003). https://doi.org/10.2165/00003088-200342060-00009

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  • DOI: https://doi.org/10.2165/00003088-200342060-00009

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