SWIFT: Prospective 48-week study to evaluate efficacy and safety of switching to emtricitabine/tenofovir from lamivudine/abacavir in virologically suppressed hiv-1 infected patients on a boosted protease inhibitor containing antiretroviral regimen

R. Campo, E. Dejesus, U. F. Bredeek, K. Henry, H. Khanlou, K. Logue, C. Brinson, P. Benson, L. Dau, H. Wang, K. White, J. Flaherty, T. Fralich, B. Guyer, D. Piontkowsky

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Abstract

Background. In the United States, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is a preferred nucleoside reverse transcriptase inhibitor (NRTI) backbone with lamivudine/abacavir (3TC/ABC) as a commonly used alternative. For patients infected with human immunodeficiency virus (HIV-1) virologically suppressed on a boosted protease inhibitor (PI) + 3TC/ABC regimen, the merits of switching to FTC/TDF as the NRTI backbone are unknown.Methods. SWIFT was a prospective, randomized, open-label 48-week study to evaluate efficacy and safety of switching to FTC/TDF. Subjects receiving 3TC/ABC + PI + ritonavir (RTV) with HIV-1 RNA < 200 c/mL ≥3 months were randomized to continue 3TC/ABC or switch to FTC/TDF. The primary endpoint was time to loss of virologic response (TLOVR) with noninferiority measured by delta of 12%. Virologic failure (VF) was defined as confirmed rebound or the last HIV-1 RNA measurement on study drug ≥200 c/mL.Results. In total, 311 subjects were treated in this study (155 to PI + RTV + FTC/TDF, 156 to PI + RTV + 3TC/ABC). Baseline characteristics were similar between the arms: 85% male, 28% black, median age, 46 years; and median CD4 532 cells/mm3. By TLOVR through week 48, switching to FTC/TDF was noninferior compared to continued 3TC/ABC (86.4% vs 83.3%, treatment difference 3.0% (95% confidence interval,-5.1% to 11.2%). Fewer subjects on FTC/TDF experienced VF (3 vs 11; P =. 034). FTC/TDF showed greater declines in fasting low-density lipoproteins (LDL), total cholesterol (TC), and triglycerides (TG) with significant declines in LDL and TC beginning at week 12 with no TC/HDL ratio change. Switching to FTC/TDF showed improved NCEP thresholds for TC and TG and improved 10-year Framingham TC calculated scores. Decreased epidermal growth factor receptor (eGFR) was observed in both arms with a larger decrease in the FTC/TDF arm.Conclusions. Switching to FTC/TDF from 3TC/ABC maintained virologic suppression, had fewer VFs, improved lipid parameters and Framingham scores but decreased eGFR.

Original languageEnglish (US)
Pages (from-to)1637-1645
Number of pages9
JournalClinical Infectious Diseases
Volume56
Issue number11
DOIs
StatePublished - Jun 1 2013

Keywords

  • 3TC/ABC
  • FTC/TDF
  • HIV-1
  • switch
  • virologic failure

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    Campo, R., Dejesus, E., Bredeek, U. F., Henry, K., Khanlou, H., Logue, K., Brinson, C., Benson, P., Dau, L., Wang, H., White, K., Flaherty, J., Fralich, T., Guyer, B., & Piontkowsky, D. (2013). SWIFT: Prospective 48-week study to evaluate efficacy and safety of switching to emtricitabine/tenofovir from lamivudine/abacavir in virologically suppressed hiv-1 infected patients on a boosted protease inhibitor containing antiretroviral regimen. Clinical Infectious Diseases, 56(11), 1637-1645. https://doi.org/10.1093/cid/cis1203