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Abstract
Efficacy and safety of tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV through 96 weeks in antiretroviral treatment-naïve patients
J. Gallant1, A. Pozniak2, E. DeJesus3, J. Arribas4, R. Campo5, S.-S. Chen6, D. McColl6, J. Enejosa6, A. Cheng6, Study 934 Team
Background: This is the first large phase III trial comparing once daily TDF, FTC and efavirenz (EFV) to twice daily CBV and once daily EFV. At week 48, the proportion of patients reaching primary endpoint of HIV RNA<400 c/mL using the FDA TLOVR algorithm was significantly higher in the TDF+FTC arm.
Methods: Ongoing phase III, multicenter, open-label, randomized trial in treatment-naïve patients with HIV RNA>10,000 c/mL and any CD4 cell count. Whole body DEXA scans were collected on available patients at week 96.
Results: Baseline characteristics (ITT, n=509) were similar between arms (median age 37, 14% female, 59% white, median HIV RNA 5.0 log10 c/mL, median CD4 237 cells/mm3). Excluding patients (n=22) with baseline NNRTI mutations, 76% in TDF+FTC arm (n=244) vs 64% in CBV arm (n=243) achieved and maintained HIV RNA<400 c/mL through Week 96 (TLOVR, 95% CI +3.9% to +20.1%, p=0.004); 69% in TDF+FTC arm vs. 63% in CBV arm achieved and maintained HIV RNA<50 c/mL (95% CI -2.0% to 14.7%, p=0.15). The mean increase in CD4 cell count from baseline was significantly greater in TDF+FTC arm (270 vs 237, p=0.036). No patient developed the K65R mutation. Significantly more patients on CBV developed M184V/I (9 vs 2, p=0.037). Adverse events leading to study regimen discontinuation (most common: anemia, nausea, fatigue, vomiting, rash) were fewer for TDF+FTC arm (5%) vs CBV arm (11%), p<0.001. The renal safety profile was similar in both arms. Median limb fat at week 96 was greater in TDF+FTC arm (7.7 kg, n=144) compared to CBV arm (5.5 kg, n=136), p<0.001.
Conclusions: Through Week 96, significantly more patients on TDF+FTC+EFV achieved HIV RNA<400 c/mL and had higher CD4 cell increase from baseline. More patients in CBV arm discontinued study regimen due to adverse events. Limb fat was significantly higher in TDF+FTC arm.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
TUPE0064
Suggested Citation
"J.Gallant, et al.
Efficacy and safety of tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV through 96 weeks in antiretroviral treatment-naïve patients.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
TUPE0064"
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