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.
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.
Palacios
R
R
Hosp. Virgen de la Victoria, Campus Teatinus s/n, Málaga, Spain.
Hidalgo
C
C
Ríos
M J
MJ
Rivero
A
A
Muñoz
L
L
Lozano
F
F
Gutiérrez-Ravé
V
V
Gálvez
M C
MC
del Arco
A
A
Santos
J
J
D000225:Adenine / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods; D018791:CD4 Lymphocyte Count; D002490:Central Nervous System / Q000187:drug effects; D015331:Cohort Studies; D003404:Creatinine / Q000652:urine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D004338:Drug Combinations; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D007668:Kidney / Q000187:drug effects; D019259:Lamivudine / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008657:Metabolic Clearance Rate / Q000187:drug effects; D008875:Middle Aged; D063065:Organophosphonates / Q000494:pharmacology / Q000627:therapeutic use; D009943:Organophosphorus Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D012307:Risk Factors; D000068698:Tenofovir; D019562:Viral Load
D019380:Anti-HIV Agents; D004338:Drug Combinations; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D012367:RNA, Viral; D003841:Deoxycytidine; D019259:Lamivudine; D000068698:Tenofovir; D003404:Creatinine; D000225:Adenine