Abstract
The objective was to evaluate the effectiveness and safety of simplification from tenofovir-lamivudine (TDF-3TC) to Truvada® (TVD) in virologically suppressed HIV patients. We carried out an open-label, multicentre, non-controlled study of HIV patients on a stable regimen including TDF-3TC who switched from TDF-3TC to TVD. Viral load responses at 24 and 48 weeks were evaluated. Changes in the calculated glomerular filtration rates (cGFR; Cockcroft-Gault equation) were analysed at baseline and at 24 and 48 weeks. Patients with drug-related nephrotoxicity (cGFR < 60 mL/min at 48 weeks or interruption of TVD because of renal toxicity) were analysed in detail. Two hundred and ninety-five patients with a mean time on TDF-3TC of 19.9 months (range 8.8–29.8) were enrolled. The third drug was a non-nucleoside reverse transcriptase inhibitor, which was administered to 187 patients (76.4% efavirenz) and a protease inhibitor was administered to 108 (43.5% lopinavir/ritonavir). At 48 weeks, 85.7% of the patients were still taking the same regimen, all with an undetectable viral load. The cGFR (mL/min) decreased from baseline (111 [89–130]) to 48 weeks (105 [84–121]); p < 0.0001. The percentage of patients with a cGFR <60 mL/min at 48 weeks was 3.5. Six patients ceased TVD because of drug-related nephrotoxicity. The only factors associated with nephrotoxicity were age, baseline weight and cGFR. Simplification from TDF-3TC to TVD was associated with a decrease in cGFR, with a low prevalence of nephrotoxicity at 48 weeks.
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Acknowledgements
On behalf 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; F. Jiménez-Oñate, Hospital Carlos Haya, Málaga.
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Palacios, R., Hidalgo, C., Ríos, M.J. et al. Effectiveness and safety of simplification from tenofovir-lamivudine (TDF-3TC) to tenofovir-emtricitabine (TDF-FTC) co-formulation (Truvada®) in virologically suppressed HIV-infected patients on HAART. Eur J Clin Microbiol Infect Dis 28, 399–402 (2009). https://doi.org/10.1007/s10096-008-0636-x
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DOI: https://doi.org/10.1007/s10096-008-0636-x