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JAC Advance Access published online on November 10, 2009
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkp402
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

Does enfuvirtide increase the risk of bacterial pneumonia in patients receiving combination antiretroviral therapy?

I. Kousignian1,2,*, O. Launay3, C. Mayaud4, C. Rabaud5, D. Costagliola1,2,6, S. Abgrall1,2,7 on behalf of the FHDH-ANRS CO4{dagger}

1 INSERM U 943, Paris, F-75013 France 2 UPMC Université Paris 06, UMR_S 943, Paris, F-75013 France 3 Assistance Publique-Hôpitaux de Paris (APH-HP), Hôpital Cochin, Pôle de Médecine, Paris, F-75014 France 4 Service de Pneumologie et Réanimation respiratoire, Hôpital Tenon, Paris, F-75970 France 5 CHU de Nancy, Service de maladies infectieuses et tropicales, Hôpitaux de Brabois, Vandoeuvre, F-54511 France 6 AP-HP, Groupe hospitalier Pitié-Salpétrière, Service des maladies infectieuses et tropicales, Paris, F-75013 France 7 AP-HP, Hôpital Avicenne, Service de maladies infectieuses et tropicales, Bobigny, F-93000 France

Received 30 June 2009; returned 3 August 2009; revised 11 October 2009; accepted 13 October 2009

* Corresponding author. Present address: Université Paris Descartes, Faculté des Sciences Pharmaceutiques et Biologiques, Laboratoire Santé Publique et Environnement-EA 4064, 4 avenue de l'Observatoire, 75006 Paris, France. Tel: +33-1-53-73-97-27; Fax: +33-1-43-25-38-76; E-mail: isabelle.kousignian{at}parisdescartes.fr

Background: Pooled analysis of the TORO comparative clinical trial data sets showed a significantly higher incidence rate (IR) of bacterial pneumonia (BP) among patients treated with enfuvirtide-containing combination antiretroviral therapy (ENF-cART) than in those treated with other cART regimens.

Objectives: To examine the possible impact of ENF-cART on the risk of BP.

Methods: From the French Hospital Database on HIV, we selected two groups of patients among cART-treated patients who were prescribed a new cART regimen during the period 2001–2006, when their CD4 counts were <350 cells/mm3. The ENF-cART and cART groups consisted of 1220 and 9374 patients, respectively. Poisson regression models were used to quantify the relationship between ENF-cART therapy and the risk of BP.

Results: At baseline the median CD4 counts were 100 and 211 cells/mm3 and the median plasma viral load (pVL) values were 60 276 and 2702 copies/mL in the ENF-cART and cART groups, respectively. The respective BP IRs were 0.65 [95% confidence interval (CI) 0.25–1.06] and 0.31 (95% CI 0.25–0.38) cases per 100 person-years. After adjustment for age, the HIV transmission group, the time period, co-trimoxazole prophylaxis, and stratified CD4 cell counts and pVL values, we found that the BP risk ratio was not increased by enfuvirtide treatment (relative rate 1.39; 95% CI 0.46–4.13). In contrast, lower CD4 cell counts and higher pVL values were significantly associated with a higher risk of BP.

Conclusions: ENF-cART is not associated with a significantly higher risk of BP than other cART regimens, although the value of the adjusted risk and the upper limit of the CI do not allow us to exclude a small increased risk.

Key Words: HIV , cART , cohort study

{dagger} Members are listed in the Acknowledgements section.


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