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Six Year Safety and Efficacy of Tenofovir DF (TDF) in Combination with Lamivudine (3TC) and Efavirenz (EFV) in Antiretroviral-Naive Patients
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Reported by Jules Levin
4th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention
July 22-25, 2007
Sydney, Australia
JVR Madruga,1 I Cassetti,2 E Koenig,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; 3Instituto Dominicano de Estudios Virologicos, Santo Domingo, Dominican Republic;
4Hospital Guilherme ēlvaro, Santos, Brazil; 5Gilead Sciences, Inc., Foster City, CA, USA
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.
AUTHOR CONCLUSIONS
Through 6 years of therapy in antiretroviral naive patients, TDF+3TC+EFV
demonstrated the following:
--Sustained, durable antiretroviral efficacy
--Continued CD4 cell count increases
--No discontinuations due to renal adverse events
--Significant increases in limb fat from years 2 through 6
--No evidence of clinically relevant bone effects
METHODS
Study 903 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 7-year (336-week) open-label extension phase (903E)
Data obtained from patients originally randomized to TDF and participating in 903E were analyzed
RESULTS
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