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. 2009 Apr;28(4):399-402. doi: 10.1007/s10096-008-0636-x. Epub 2008 Oct 8.

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.

Publication types

  • Multicenter Study

MeSH terms

  • Adenine / analogs & derivatives
  • Adenine / pharmacology
  • Adenine / therapeutic use
  • Adult
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / pharmacology
  • Anti-HIV Agents / therapeutic use*
  • Antiretroviral Therapy, Highly Active* / adverse effects
  • Antiretroviral Therapy, Highly Active* / methods
  • CD4 Lymphocyte Count
  • Central Nervous System / drug effects
  • Cohort Studies
  • Creatinine / urine
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / pharmacology
  • Deoxycytidine / therapeutic use
  • Drug Combinations
  • Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1 / drug effects
  • HIV-1 / isolation & purification
  • Humans
  • Kidney / drug effects
  • Lamivudine / pharmacology
  • Lamivudine / therapeutic use
  • Male
  • Metabolic Clearance Rate / drug effects
  • Middle Aged
  • Organophosphonates / pharmacology
  • Organophosphonates / therapeutic use
  • Organophosphorus Compounds / adverse effects
  • Organophosphorus Compounds / pharmacology
  • Organophosphorus Compounds / therapeutic use*
  • RNA, Viral / blood
  • Retrospective Studies
  • Risk Factors
  • Tenofovir
  • Viral Load

Substances

  • Anti-HIV Agents
  • Drug Combinations
  • Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Organophosphonates
  • Organophosphorus Compounds
  • RNA, Viral
  • Deoxycytidine
  • Lamivudine
  • Tenofovir
  • Creatinine
  • Adenine