JAC Advance Access originally published online on December 21, 2007
Journal of Antimicrobial Chemotherapy 2008 61(2):462-463; doi:10.1093/jac/dkm489
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Research letters |
Minor emtricitabine intolerance in treatment-stable patients switched from tenofovir/lamivudine to a fixed-dose combination of tenofovir/emtricitabine (Truvada®)
1 Hospital Virgen de la Victoria, Málaga, Spain 2 Hospital de Jerez, Spain 3 Hospital Reina Sofía, Córdoba, Spain
* Corresponding author. Tel: +34-951032594; Fax: +34-951032593; E-mail: med000854{at}saludalia.com
Keywords: antiretroviral therapy , adverse reactions , treatment
Emtricitabine 1 has characteristics similar to lamivudine with respect to activity, safety and resistance profile, and according to the current treatment guidelines, the two drugs are interchangeable.2 As the fixed-dose combination of emtricitabine and tenofovir was approved (Truvada®) (TVD), tenofovir and lamivudine have been replaced in many patients by TVD for convenience.
We report the safety of simplification from tenofovir/lamivudine to TVD in virologically suppressed HIV-infected patients on highly active antiretroviral therapy between November 2005 and May 2006 in 10 Spanish hospitals. This study was designed and conducted according to the principles of the declaration of Helsinki. It was approved by the Ethics Committee of the Hospital Virgen de la Victoria. Of the 295 patients who underwent the change from tenofovir/lamivudine to TVD, 6 (2%) suspended emtricitabine due to adverse effects. In all six cases, lamivudine was reintroduced with no problems and viral suppression was maintained. The reasons for suspension were neurological symptoms in five patients and hyperpigmentation of the palms of the hands in one patient. The symptoms in the five patients with CNS toxicity, which appeared during the first 3 days after the switch, were insomnia, irritability and confusion. One of the five patients with CNS symptoms also experienced nausea and vomiting (Table 1). All other patients tolerated the new combination well.
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Although lamivudine and emtricitabine may theoretically be comparable, small differences exist, including a varying pattern of adverse effects resulting in some patients being unable to tolerate emtricitabine. An earlier study found that 8% of the patients who changed from lamivudine to emtricitabine had to stop it during the first month due to adverse effects, mostly neurological.3 In another study, the change from lamivudine to emtricitabine was associated with a 3% rate of discontinuation due to adverse effects, again as a result of neurological symptoms.4 Whatever the case, the percentage of patients who have to suspend emtricitabine due to adverse effects, mainly neurological symptoms, is small and most patients can switch from lamivudine to emtricitabine for convenience with no problems.
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Funding |
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 Top Funding Transparency declarationsReferences |
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No specific funding has been received for this work.
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Transparency declarations |
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TopFundingTransparency declarationsReferences |
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None to declare.
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Footnotes |
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Members of the SIMVA Group are listed in the Acknowledgements section. 
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Acknowledgements |
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Members of the SIMVA Group: J. Santos, A. Hidalgo and R. Palacios, Hospital Virgen de la Victoria, Málaga; A. Terrón, Hospital de Jerez; A. Rivero, Hospital Reina Sofía, Córdoba; M. J. Ríos, Hospital Virgen Macarena, Sevilla; L. Muñoz, Hospital San Cecilio, Granada; C. Hidalgo, M. López, J. Pasquau and M. A. López-Ruz, Hospital Virgen de las Nieves, Granada; M. C. Gálvez, Hospital Torrecárdenas, Almería; A. Del Arco, Hospital Costa del Sol, Marbella; V. Gutiérrez-Ravé, Hospital de Motril; F. Lozano, Hospital de Valme, Sevilla; and F. Jiménez-Oñate, Hospital Carlos Haya, Málaga.
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References |
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TopFundingTransparency declarationsReferences |
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1 Bang LM, Scott LJ. Emtricitabine: an antiretroviral agent for HIV infection. Drugs (2003) 63:2413–24. discussion 2425–6.[CrossRef][Web of Science][Medline]
2 Benson CA, van der Horst C, Lamarca A, et al. A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV. AIDS (2004) 18:2669–76.
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Pollock K, Stebbing J, Bower M, et al. Emtricitabine intolerance in treatment-experienced patients switched from lamivudine: a method of assessing toxicity. J Antimicrob Chemother (2006) 58:227–8.
4 Villar del Saz S, Milinkovic A, Domingo P, et al. Tolerability of emtricitabine (FTC) in HIV infected subjects who switch from lamivudine (3TC) to FTC. Abstracts of the Fourth IAS Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, 2007. Abstract MOPEB012.
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