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The Safety and Efficacy of Switching Stavudine to
Tenofovir DF in Combination with Lamivudine and
Efavirenz in HIV-1-Infected Patients: A Four-Year Follow-up
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Reported by Jules Levin
IAC Aug 3-8 2008 Mexico City
JVR Madruga,1 I Cassetti,2 J Suleiman,3 A Etzel,4 Y Zhou,5 AK Cheng,5 and J Enejosa5 for the 903E Study Team. 1Centro de Referencia e Treinamento DST/AIDS, Sao Paulo, Brazil; 2Fundacion Centro Estudios Infectologicos, Buenos Aires, Argentina; 3Brasilmed Assistencia Medica e Pesquisas, Sao Paulo, Brazil; 4Hospital Guilherme ēlvaro, Santos, Brazil; 5Gilead Sciences, Inc., Foster City, CA
Switching from d4T to TDF in combination with 3TC+EFV through 4 years demonstrated the following:
-- Maintenance of virologic suppression and continued immunologic improvement
--Significant decreases in serum triglycerides and cholesterol
--No changes in spine BMD and small but statistically significant decreases in hip BMD
No patient experienced pathologic fractures
--Significant increase in limb fat
BACKGROUND
Study 903 is a Phase III trial with an ongoing 336-week open-label extension phase and a completed 144-week randomized, double-blind phase designed to evaluate TDF compared to stavudine (d4T) in combination with 3TC and EFV in antiretroviral-naive patients
METHODS
Study 903 main inclusion/exclusion criteria:
--HIV-infected patients naive to antiretroviral treatment, 18-65 years of age, with plasma HIV RNA > 5,000 copies/mL (c/mL)
--No significant laboratory or clinical abnormalities
--No CD4+ cell count criteria
Patients in select sites (Argentina, Brazil, and Dominican Republic) rolled-over into a 336-week open-label extension phase (903E)
Data obtained from patients participating in 903E who switched d4T to TDF were analyzed
Patient Disposition Through 4 Years After Switch
85 patients in the d4T arm switched d4T to TDF
11 patients discontinued from the study prior to Year 4 (192 weeks after Switch)
--1 patient died from septic shock due to pneumonia
--1 patient experienced virologic failure
--1 patient discontinued due to abnormal renal function
Decrease in estimated GFR by Cockcroft-Gault from 79 at time of switch to 49 mL/min at open-label Week 120; Study drug was subsequently discontinued and estimated GFR improved to 55 mL/min; GFR remained stable at 55 mL/min approximately 3 months after discontinuation
--1 patient discontinued due to pregnancy
--7 patients withdrew consent, were non-compliant, lost to follow-up or other reason
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