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

  • R. Palacios
  • C. Hidalgo
  • M. J. Ríos
  • A. Rivero
  • L. Muñoz
  • F. Lozano
  • V. Gutiérrez-Ravé
  • M. C. Gálvez
  • A. del Arco
  • J. Santos
Concise Article

DOI: 10.1007/s10096-008-0636-x

Cite this article as:
Palacios, R., Hidalgo, C., Ríos, M.J. et al. Eur J Clin Microbiol Infect Dis (2009) 28: 399. doi:10.1007/s10096-008-0636-x

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.

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • R. Palacios
    • 1
  • C. Hidalgo
    • 2
  • M. J. Ríos
    • 3
  • A. Rivero
    • 4
  • L. Muñoz
    • 5
  • F. Lozano
    • 6
  • V. Gutiérrez-Ravé
    • 7
  • M. C. Gálvez
    • 8
  • A. del Arco
    • 9
  • J. Santos
    • 1
  1. 1.Unidad de Enfermedades InfecciosasHosp. Virgen de la VictoriaMálagaSpain
  2. 2.Hosp. Virgen de las NievesGranadaSpain
  3. 3.Hosp. Virgen MacarenaSevillaSpain
  4. 4.Hosp. Reina SofíaCórdobaSpain
  5. 5.Hosp. San CecilioGranadaSpain
  6. 6.Hosp. de ValmeSevillaSpain
  7. 7.Hosp. de MotrilMotrilSpain
  8. 8.Hosp. TorrecárdenasAlmeríaSpain
  9. 9.Hosp. Costa del SolMarbellaSpain