JAC Advance Access originally published online on July 28, 2008
Journal of Antimicrobial Chemotherapy 2008 62(5):1122-1129; doi:10.1093/jac/dkn309
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Original research |
Switch from zidovudine- to non-zidovudine-containing regimens is associated with modest haematological improvement and no obvious clinical benefit: a substudy of the ANRS 099 ALIZE trial
1 Department of Infectious Diseases, Saint-Louis Hospital, University of Paris 7, INSERM U897, 1 avenue Claude Vellefaux 75010 Paris, France 2 University Victor Segalen Bordeaux 2, Centre INSERM U897, 146 rue Leo Saignat—Case 11 33076 Bordeaux Cedex, France 3 Department of Internal Medicine, Avicenne Hospital, 125 rue de Stalingrad, 93000 Bobigny, France 4 Department of Infectious Diseases, Cavale Blanche Hospital, 29200 Brest, France 5 Department of Infectious Diseases, Bichat Hospital, University of Paris 7, 46 rue Henri-Huchard, 75018 Paris, France 6 Department of Immunology, Henri Mondor Hospital, Paris, France 7 University Paris 12, INSERM U841, 51 avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France 8 Department of Internal Medicine, Kremlin Bicetre Hospital, 78 rue du Général Leclerc, 94000 Le Kremlin-Bicetre, France
Received 9 May 2008; returned 11 June 2008; revised 5 July 2008; accepted 7 July 2008
* Corresponding author. Tel: +33-142499066; Fax: +33-142499067; E-mail: jean-michel.molina{at}sls.aphp.fr
Background: Zidovudine, the first antiretroviral agent, has short-term haematological toxicity. However, it is unclear whether patients tolerating long-term zidovudine-containing regimens will benefit from a switch to non-zidovudine-containing regimens.
Methods: One hundred and fifty-eight patients enrolled in the ALIZE trial receiving zidovudine at baseline were analysed. These patients were randomized to continue their regimen or to switch to a combination of emtricitabine, didanosine and efavirenz for 48 weeks. Changes from baseline in haemoglobin (Hb), neutrophil and platelet counts were compared between arms as well as the occurrence of cardiovascular events, bacterial infections, use of haematopoietic growth factors, blood transfusion and quality of life using the Medical Outcome Study HIV (MOS-HIV) health survey.
Results: Eighty-one patients continued their regimen and 77 switched. At 48 weeks, mean change from baseline in Hb were +0.73 and –0.37 g/dL in the switch and maintenance groups, respectively (P < 0.01). Mean neutrophil counts increased by 592 and 51 cells/mm3 in the switch and maintenance groups, respectively (P = 0.02). The occurrence of cardiovascular events or bacterial infections was similar in both treatment arms with no use of haematopoietic growth factors or blood transfusion. Also, mean change from baseline in MOS-HIV physical and mental health summary scores was similar in both arms.
Conclusions: A switch from a long-standing zidovudine- to a non-zidovudine-containing regimen modestly improves haematological parameters and is not associated with obvious clinical benefit.
Keywords: HAART , haemoglobin , neutrophil , quality of life , bacterial infection
ALIZE Study Group members are listed in the Acknowledgements section.