Abstract

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Three-year safety and efficacy of emtricitabine (FTC)/tenofovir DF (TDF) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV in antiretroviral treatment-naïve patients

Presented by Jose R Arribas, Spain.

Arribas J.¹, Pozniak A.², Gallant J.³, DeJesus E.⁴, Campo R.⁵, Chen S.-S.⁶, McColl D.⁶, Cheng A.⁶, Enejosa J.⁶, Study 934 Team

¹Hospital Universitario La Paz, Madrid, Spain, ²Chelsea and Westminster Hospital, London, United Kingdom, ³Johns Hopkins University School of Medicine, Baltimore, MD, United States, ⁴Orlando Immunology Center, Orlando, FL, United States, ⁵University of Miami, Miami, FL, United States, ⁶Gilead Sciences, Foster City, CA, United States

Objectives: The once-daily regimen of FTC+TDF+EFV demonstrated superior outcomes compared to twice daily CBV and once daily EFV through 48 weeks in antiretroviral-naïve patients. Results through 3 years of treatment (144 weeks) are analyzed.
Methods: Study 934 is an ongoing phase III, multicenter, open-label trial in treatment-naïve patients with HIV RNA >10,000 c/mL and any CD4 cell count who were randomized to receive FTC+TDF+EFV or CBV+EFV. Patients on FTC+TDF received the fixed-dose combination (Truvada®, TVD) starting at Week 96.
Results: Baseline (BL) characteristics (ITT, n=509) were similar (median age 37, 14% female, 59% white, median HIV RNA 5.0 log₁₀ c/mL, median CD4 237 cells/mm³). 71% in TVD arm vs. 58% in CBV arm achieved and maintained HIV RNA <400 c/mL through Week 144 (TLOVR, efficacy population; 95% CI of the difference +4.2% to +21.6%, p=0.004); 64% in TVD arm vs. 56% in CBV arm achieved and maintained HIV RNA <50 c/mL (95% CI of the difference -0.8% to 17%, p=0.08). Mean increase from BL in CD4 cell count was 312 in TVD arm and 271 in CBV arm (p=0.09). Significantly more patients in CBV arm developed the M184V/I mutation (10 vs. 2, p=0.02). No patient developed K65R. More patients in CBV arm discontinued study regimen due to adverse events (11% vs. 5%, p<0.01). No patient discontinued due to renal events. Median total limb fat at Week 144 was greater in TVD arm (7.9 kg, n=145) vs. CBV arm (5.4 kg, n=124), p<0.001.
Conclusions: Through 3 years, significantly more patients on TVD+EFV achieved and maintained HIV RNA<400 c/mL with no patient developing the K65R mutation. The long-term safety and tolerability of TVD+EFV was demonstrated through 3 years of treatment with fewer discontinuations due to adverse events and no discontinuations due to renal events. Patients on TVD+EFV had greater limb fat than those on CBV+EFV.

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