3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

SUPERIOR OUTCOME FOR TENOFOVIR DF (TDF), EMTRICITABINE (FTC) AND EFAVIRENZ (EFV) COMPARED TO FIXED DOSE ZIDOVUDINE/LAMIVUDINE (CBV) AND EFV IN ANTIRETROVIRAL NAÏVE PATIENTS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOa0202

Pozniak A.L.¹, Gallant J.E.², DeJesus E.³, Campo R.⁴, Arribas J.R.⁵, Gazzard B.¹, Lu B.⁶, McColl D.⁶, Enejosa J.⁶, Cheng A.K.^6
1Chelsea and Westminster Hospital, London, United Kingdom, ²Johns Hopkins University School of Medicine, Baltimore, United States of America, ³Orlando Immunology Center, Orlando, United States of America, ⁴University of Miami, Miami, United States of America, ⁵University Hospital La Paz, Madrid, Spain, ⁶Gilead Sciences, Foster City, United States of America

INTRODUCTION: This is the first trial comparing once daily TDF, FTC and efavirenz (EFV) to twice daily CBV and EFV once daily.

METHODS: Ongoing 96-week, phase III, open-label non-inferiority trial in treatment naïve patients with HIV RNA >10,000 c/mL. Patients were randomized to receive TDF, FTC and EFV or CBV+EFV. The primary efficacy endpoint was the proportion of patients achieving and maintaining HIV RNA <400 c/mL at week 48 using the FDA Time to Loss of Virologic Response (TLOVR) algorithm.

RESULTS: The ITT population (n=509) had a mean age of 38 years, mean HIV RNA 5.0 log₁₀ c/mL, mean CD4 245/mm³ and was 86% male. Preliminary analyses demonstrated that using the TLOVR algorithm, 81% in the TDF+FTC arm (n=255) vs 71% in the CBV arm (n=254) achieved and maintained HIV RNA <400 c/mL through Week 48 (95% CI +3.4% to +18.1%, p=0.005). Virologic rebound occurred in <1% of patients in the TDF+FTC arm vs. 4% of CBV patients, p=0.021. Similarly, 77% in the TDF+FTC arm vs 69% in the CBV arm achieved and maintained HIV RNA <50 c/mL through Week 48 (95% CI +0.5% to +15.8%, p=0.042). The increase in CD4 count from baseline was significantly greater in the TDF+FTC arm (189 cells/mm³ vs. 158, p=0.002). Adverse events leading to study regimen discontinuation (most common: anemia, nausea, fatigue, vomiting) were fewer for TDF+FTC arm (4%) vs CBV arm (9%), p=0.016. No patient discontinued study regimen due to renal adverse events. No patient developed the K65R mutation.

CONCLUSIONS: Through week 48, the combination of TDF, FTC and EFV compared to CBV + EFV fulfilled the criteria for non inferiority and resulted in a superior outcome in terms of virologic suppression, CD4 response, and adverse events leading to study regimen discontinuation.

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050724
Clinical | WeOa0202 | A.l. Pozniak
Phase III/IV trials

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