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/mm3; 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.
From the *Chelsea and Westminster Hospital, London, United Kingdom; †Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD; ‡Orlando Immunology Center, Orlando, FL; §Hospital de La Paz, Madrid, Spain; ‖University of Miami, Miami, FL; and ¶Gilead Sciences, Foster City, CA.
Received for publication June 12, 2006; accepted September 12, 2006.
Funded by Gilead Sciences.
A. L. Pozniak and J. R. Arribas report receiving consulting and lecture fees from Bristol-Myers Squibb (BMS), Gilead Sciences, and GlaxoSmithKline (GSK). J. E. Gallant reports receiving consulting and/or lecture fees from BMS, Gilead Sciences, and GSK, and receives grant support from Boehringer Ingelheim (BI), BMS, and Gilead Sciences. E. DeJesus and B. Gazzard have received consulting and lecture fees from BI, BMS, Gilead Sciences, and GSK. R. E. Campo reports receiving consulting fees from Gilead Sciences and grant support from Gilead Sciences and BMS. S.-S. Chen, A. K. Cheng, J. Enejosa, D. McColl, and J. J. Toole are employees and stockholders of Gilead Sciences.
Reprints: Andrew K. Cheng, MD, PhD, Gilead Sciences, 300 Lakeside Drive, Foster City, CA 94404 (e-mail: firstname.lastname@example.org).