The Safety and Efficacy of Tenofovir DF in Combination with Lamivudine and Efavirenz Through 6 Years in Antiretroviral-Naïve HIV-1—Infected Patients
- 1 June 2007
- journal article
- research article
- Published by Informa UK Limited in HIV Research & Clinical Practice
- Vol. 8 (3), 164-172
- https://doi.org/10.1310/hct0803-164
Abstract
Background: Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) and an ongoing additional 336-week open-label extension phase. Method: Patients in Brazil, Argentina, and the Dominican Republic who completed the 144-week double-blind phase on TDF were eligible to roll over to the extension phase (weeks 144-480). Results from an interim week 288 analysis are presented. Results: Eighty-six patients (62% male, 70% white) initially randomized to the TDF arm continued treatment with TDF. At the end of the 144-week, double-blind phase, 85 of the 86 had HIV-1 RNA 3 from entry into the open-label extension to week 288. No patient discontinued due to renal adverse events. Small changes in bone mineral density at the lumbar spine and hip were seen in the first 48 weeks but were nonprogressive through 288 weeks. Mean limb fat increased from 8.0 kg at week 96 to 8.8 kg at week 288. Conclusion: Through 288 weeks, once-daily TDF+3TC+EFV demonstrated sustained antiretroviral activity with continued immunologic recovery. TDF treatment was not associated with renal adverse events or limb fat loss in antiretroviral-naïve patients.Keywords
This publication has 9 references indexed in Scilit:
- Tenofovir DF, Emtricitabine, and Efavirenz vs. Zidovudine, Lamivudine, and Efavirenz for HIVNew England Journal of Medicine, 2006
- Reply to GuptaClinical Infectious Diseases, 2005
- Changes in Renal Function Associated with Tenofovir Disoproxil Fumarate Treatment, Compared with Nucleoside Reverse‐Transcriptase Inhibitor TreatmentClinical Infectious Diseases, 2005
- Renal Dysfunction With Tenofovir Disoproxil Fumarate-Containing Highly Active Antiretroviral Therapy Regimens Is Not Observed More FrequentlyJAIDS Journal of Acquired Immune Deficiency Syndromes, 2004
- Efficacy and Safety of Tenofovir DF vs Stavudine in Combination Therapy in Antiretroviral-Naive PatientsA 3-Year Randomized TrialJAMA, 2004
- Osteoporosis Prevention, Diagnosis, and TherapyJAMA, 2001
- A More Accurate Method To Estimate Glomerular Filtration Rate from Serum Creatinine: A New Prediction EquationAnnals of Internal Medicine, 1999
- Declining Morbidity and Mortality among Patients with Advanced Human Immunodeficiency Virus InfectionNew England Journal of Medicine, 1998
- Prediction of Creatinine Clearance from Serum CreatinineNephron, 1976