Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-Week analysis

Jose R. Arribas, Anton L. Pozniak, Joel E. Gallant, Edwin DeJesus, Brian Gazzard, Rafael E. Campo, Shan Shan Chen, Damian McColl, Charles B. Holmes, Jeffrey Enejosa, John J. Toole, Andrew K. Cheng

Research output: Contribution to journalArticle

Abstract

BACKGROUND: As antiretroviral regimens for the treatment of HIV infection improve, trials providing data on long-term follow-up are increasingly important. METHODS: A regimen of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) demonstrated superior virologic, immunologic and morphologic effects compared with a regimen of fixed-dose zidovudine/lamivudine (ZDV/3TC) and EFV through 96 weeks in a randomized open-label trial. After 96 weeks, patients on TDF + FTC transitioned to fixed-dose combination TDF/FTC. RESULTS: Through 144 weeks, significantly more patients in the TDF/FTC arm reached and maintained an HIV RNA level <400 copies/mL (71% receiving TDF/FTC and EFV vs. 58% receiving ZDV/3TC and EFV; P = 0.004), with a trend toward greater CD4 cell increase in the TDF/FTC arm (312 vs. 271 cells/mm; P = 0.09). Over 144 weeks of follow-up, more patients in the ZDV/3TC arm discontinued therapy because of adverse events (11% vs. 5%; P = 0.01) and no patients discontinued because of renal events. Patients in the ZDV/3TC arm had significantly less limb fat than patients in the TDF/FTC arm (5.4 vs. 7.9 kg; P < 0.001) at 144 weeks. CONCLUSIONS: Cumulative results from 3 years of follow-up suggest that a regimen of TDF/FTC and EFV demonstrates superior durability of viral load suppression and an improved safety and morphologic profile compared with ZDV/3TC and EFV.

Original languageEnglish (US)
Pages (from-to)74-78
Number of pages5
JournalJournal of acquired immune deficiency syndromes
Volume47
Issue number1
DOIs
StatePublished - Jan 1 2008
Externally publishedYes

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Keywords

  • Antiretroviral naive
  • Emtricitabine
  • Lamivudine
  • Lipoatrophy
  • Tenofovir
  • Zidovudine

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Arribas, J. R., Pozniak, A. L., Gallant, J. E., DeJesus, E., Gazzard, B., Campo, R. E., Chen, S. S., McColl, D., Holmes, C. B., Enejosa, J., Toole, J. J., & Cheng, A. K. (2008). Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-Week analysis. Journal of acquired immune deficiency syndromes, 47(1), 74-78. https://doi.org/10.1097/QAI.0b013e31815acab8