Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: Virologic, immunologic, and morphologic changes - A 96-week analysis

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

Research output: Contribution to journalArticle

193 Scopus citations

Abstract

BACKGROUND: In antiretroviral-naive patients, tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) demonstrated superior outcomes compared with fixed-dose zidovudine (ZDV)/lamivudine (3TC) and EFV through 48 weeks. Results through a 96-week extension phase are presented. METHODS: In this randomized, open-label, noninferiority trial, 517 antiretroviral-naive HIV-infected patients received TDF, FTC, and EFV (TDF + FTC + EFV) or ZDV/3TC and EFV (ZDV/3TC + EFV). The primary endpoint was the proportion of patients with an HIV RNA level <400 copies/mL in patients without baseline nonnucleoside resistance. RESULTS: Through week 96, significantly more patients receiving TDF + FTC + EFV achieved and maintained an HIV RNA level <400 copies/mL (75% receiving TDF + FTC + EFV vs. 62% receiving ZDV/3TC + EFV; P = 0.004). There was a trend toward greater virologic suppression to <50 copies/mL in the TDF + FTC + EFV group (67% vs. 61%; P = 0.16). The TDF + FTC + EFV group demonstrated a significantly greater increase in CD4 count (270 vs. 237 cells/mm; P = 0.036). No patient developed the K65R mutation. Limb fat at week 96 was significantly greater in the TDF + FTC + EFV group versus the ZDV/3TC + EFV group (7.7 vs. 5.5 kg; P < 0.001). CONCLUSION: Over 96 weeks, the combination of TDF, FTC, and EFV was superior to fixed-dose ZDV/3TC + EFV for achieving and maintaining an HIV RNA level <400 copies/mL and an increase in CD4 cells.

Original languageEnglish (US)
Pages (from-to)535-540
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume43
Issue number5
DOIs
StatePublished - Dec 1 2006

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Keywords

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

ASJC Scopus subject areas

  • Virology
  • Immunology

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